clinical research associate course uk

CLINICAL RESEARCH ASSOCIATE (CRA) BEGINNER

As a CRA you'll be responsible for the managerial aspects of various clinical trials at every stage of the process.

Very good course! The group discussions and the anecdotes/industry insight provided was extremely helpful. Talking to the tutor and other delegates with experience and insight into the role of a CRA was invaluable.

Jacob Lawman, Clinical Data Management & Monitoring Associate Research Organisation (KC) Ltd

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All our courses are accredited by CPD, the UK's largest independent accreditation service, and delivered by highly experienced clinical professionals.

Receive your industry recognised certification at the end of the course and your learners reference manual!

What prior knowledge is needed.

Most CRA positions require as a minimum a BSc in:

• Biological/life sciences
• Related medical field or a nursing qualification

However, in some cases, CRAs have entered the profession without a graduate degree but have the relevant expertise. The most important thing is having the right skills for the job.

Read our blog: Could A Clinical Research Associate (CRA) Position Be The Role For You?

COURSE DESCRIPTION

If you are looking to enter the field of clinical research, this CPD-accredited 3-day course is for you. It will provide you with a comprehensive insight into an entry-level Clinical Research Associate (CRA) role.

This fundamental "how-to" and "why" course, focuses on current practice. You will learn about the CRA's role and responsibilities in the context of the regulations and rules that govern clinical trials. You will look at a day in a CRA's life to gain insight into the profession. Alongside this, you will review mock-up sample protocols and study documents to reinforce your learning.

For information on the intermediate or advanced level CRA course, please send us an email at [email protected] or book a consultation with us.

What will be covered in this course?

This module will look at:

• The primary duties of a CRA
• The specific responsibilities in accordance with ICH-GCP
• SOP and regulations for before, during and after a clinical trial
• Essential documents — Preparation, collation and QC
• Ethics and regulatory submissions and approvals of the clinical trial application
• Study start-up activities — site identification and selection, QC for IP release
• Site activation — SIV, ISF review and drug supply review
• Monitoring and site management
• Study site closeout activities

You will also be guided through some real-life practical training that you will experience on the job.

• Scenario based training
• Group workshops
• Review a Monitoring Plan for a clinical trial
• First-hand review and practical use of drug accountability logs, and returned investigational product kits
• Video: A Day in the Life of a Clinical Research Associate

Excellent course, excellent tutor, really knew her stuff. A lot of material covered. Gained huge knowledge of the role of a CRA.

Angeline Nwoko, CTA, London

Who is the course designed for?

If you are a clinical trial administrator who has just been promoted to a CRA level I or have limited experience as a CRA, this modular training is specifically designed for you.

This is a good starter course that will equip you with the skills to conduct clinical trial initiation and/or monitoring and basic site management at the investigational site.

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MEET YOUR EXPERT TRAINERS

With a BSc in Chemistry, PhD in Organic Chemistry and a Postdoctoral Research Fellowship at the Institute of Biotechnology at Cambridge University, Dr Lia Hunter's career has spanned 30 years in clinical research. Founder and Director of both CGX Training and Clinnovate Ltd, Dr Hunter has worked for and with world-renowned pharmaceutical organisations, including Pfizer, Biogen, Takeda and AbbVie.

Donna-Marie Donalds’ career has spanned more than 20 years. Starting as a CRA for the Thrombosis Research Institute in 2001, she has since worked with the likes of Johnson & Johnson, Covance and Sanofi-Aventis. She is currently the Managing Director of QC Monitoring Solutions while freelancing as a clinical research consultant. Donna-Marie is also Head of Training and the innovative course creator at CGX Training.

IT'S TIME TO INVEST IN YOURSELF

Stepping into the clinical research industry can feel overwhelming. if you don't know where to start...start here.

If you’re a clinical trial administrator who has just been promoted to a clinical research Associate level I or currently a CRA that wants to ensure you’re performing to GOLD STANDARD so you can progress in your career, this is the course for you.

The CRA course has been specifically designed with live mock scenarios to arm you with the on-the-job skills you need. Plus, you'll also be carefully guided through the job application process, with insider tips on how to create a standout CV and nail that interview.

Want to see where one of our CRA trainees is now?

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Clinical research associate

Clinical drug research is a competitive but growing field and work experience in a scientific or healthcare environment is crucial for a job as a clinical research associate

As a clinical research associate (CRA), you'll run clinical trials to test drugs for their effectiveness, risks and benefits to ensure that they are safe for the intended use.

You'll work on new and existing drugs and will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial.

Clinical trials may be carried out at various stages or phases and include trials on healthy humans, trials on patients with a disease, and studies conducted after the launch of a new drug to monitor safety and side effects.

Responsibilities

Tasks vary depending on your employer and level of experience. However, you'll typically need to:

• develop and write trial protocols (outlining purpose and methodology)
• present trial protocols to a steering committee
• design data collection forms, known as case report forms (CRFs)
• coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
• manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
• identify and assess the suitability of facilities to use as the clinical trial site
• identify/select an investigator who will be responsible for conducting the trial at the trial site
• liaise with doctors, consultants or investigators on conducting the trial
• set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
• train the site staff to trial-specific industry standards
• monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
• verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• collect completed CRFs from hospitals and general practices
• write visit reports and file and collate trial documentation and reports
• meet with team members to discuss on-going trials, results and any trends or adverse events
• ensure all unused trial supplies are accounted for
• close down trial sites on completion of the trial
• discuss results with a medical statistician, who writes technical trial reports
• archive study documentation and correspondence
• prepare final reports and occasionally manuscripts for publication.
• Starting salaries for CRAs are in the region of £26,000 to £34,000. It's likely these posts will require some experience in a related area.
• As a senior CRA (SCRA), also known as a CRA II, you can earn a salary of around £35,000 to £50,000.
• In some senior roles, as a manager or director, salaries of in excess of £55,000 can be achieved.

Salaries vary from company to company. Additional benefits, such as a car allowance and bonus and pension, are typically offered.

Income figures are intended as a guide only.

Working hours

Working conditions vary between companies, although the hours are usually full time, Monday to Friday. You should expect to work some evenings, although weekend or shift work is uncommon.

Part-time work is possible, as are career breaks. Short term contracts of six to 12 months with a company are common, meaning you may work more like a contractor than a permanent employee.

What to expect

• It's likely your role will be a mixture of desk-based work and site visits. You'll visit trial sites to set up and close down a trial as well as to monitor the trial while it is running which could involve visits every four to six weeks. Some trials may be running abroad which will involve international travel. There may be opportunities for home-working the remainder of the time. In some instances you may find a role that is almost exclusively office-based with the focus being on document review.
• Most UK pharmaceutical companies are located in the south of England. Field-based positions are generally found in key locations throughout the UK. Some jobs, for example in a company laboratory, can be found locally, while others are regionally based.
• Self-employment or freelance work is possible once you've gained significant experience.
• The job can involve a lot of travelling and you may be out of the office three or four days a week, possibly including overnight stays. Some companies operate a system whereby the CRA specialises in a specific disease area and covers the whole of the UK. Others operate their CRAs on a regional basis.
• Initiatives are in place to encourage more women into science-based careers, such as Women in STEM .

Qualifications

To become a clinical research associate (CRA) you need to have a degree in life sciences, medical sciences or nursing.

This could include subjects such as:

• biochemistry
• biomedical science
• microbiology
• molecular biology
• pharmacology or pharmacy
• toxicology.

Entry without a degree or with a HND only is unlikely. You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator/assistant. However, you would need substantial experience and further qualifications to progress to the role of CRA.

A postgraduate qualification is not essential, with many employers only looking for a related undergraduate degree. However, it could give you valuable experience in clinical trials and may be an advantage against competition when applying for jobs. A relevant PhD can also be advantageous in some companies, who may consider it as highly-relevant work experience counting towards gaining promotion to senior positions or moving into protocol development. Check with desired employers to find out what they're looking for.

Search for postgraduate courses in clinical research or clinical trials .

You'll need to have:

• excellent communication, both written and verbal, and interpersonal skills
• the ability to build effective relationships with trial centre staff and colleagues
• the ability to motivate others
• strong customer focus
• an excellent grasp of numeracy and a keen eye for detail
• presentation skills
• the ability to multitask and think on your feet
• project management skills
• a flexible and adaptable approach to work
• organisational, IT and administrative skills - the job involves a lot of documenting and recording information through computerised processes, such as clinical trial management systems and electronic data capture
• an understanding of the importance of good clinical practice (GCP) , which is a legal requirement for all CRAs.

You'll usually need a clean driving licence for travel between trial sites and your office.

Skills in an additional language, particularly any European ones, may also be useful for roles abroad.

Work experience

Relevant experience is crucial for securing a job as a CRA. Without it, you're likely to start work at a lower level, as a clinical data coordinator or clinical trials administrator/assistant, where you won't be involved in initiating or designing the trials. Once you've gained experience, you will then move on to a full CRA position.

A small number of companies may recruit graduates without experience if they have the necessary personal skills, but it's more likely that employers will look for someone who has some actual experience in a related workplace. This can include any work that uses scientific and analytical skills, for example:

• academic or pharmaceutical research
• clinical data work
• clinical laboratory work
• medical sales
• nursing or care work

Another useful way of gaining experience is to complete an industrial placement as part of your undergraduate degree. This can give you the real-world experience in a related area as well as helping you to make contacts that could lead to potential job offers in the future.

Competition for jobs is strong and work experience in a clinically-relevant field will considerably improve your chances.

For free mentoring resources and experiences designed to support aspiring healthcare and legal professionals - including virtual work experience that is accepted by medical schools, see Medic Mentor .

Find out more about the different kinds of  work experience and internships  that are available.

Typical employers include pharmaceutical companies, medical device manufacturers, biotech companies and contract research organisations (CROs), which conduct research on behalf of pharmaceutical companies.

A CRO will organise the placement of a CRA on behalf of the sponsor (the pharmaceutical company) and may be involved in planning, organising and conducting the whole study or just part of it. The CRA will report back to the organisation and will feed back to the sponsor.

Large contract organisations are more likely to recruit an inexperienced graduate into a monitoring role and provide the training to progress to the level of a CRA.

Hospital academic departments occasionally employ CRAs in clinical trials units.

Look for job vacancies at:

• BMJ Careers
• emedcareers
• New Scientist Jobs
• Pharmiweb Jobs

Contract research organisations and pharmaceutical companies may advertise vacancies on their own websites.

Specialist recruitment agencies also handle vacancies. These include AL Solutions and RBW Consulting .

Professional development

Training takes place mainly in-house and on the job. The nature of the training can vary from company to company, with some employers providing a structured system.

Some companies will pay for relevant external training courses through organisations such as the Institute of Clinical Research (ICR) . They provide training in areas such as:

• advanced monitoring
• effective project management for clinical trials
• essentials of clinical trial monitoring
• process thinking in clinical trials.

You can also complete the ICR Certificate and Diploma to provide evidence of your clinical research knowledge and skills.

Becoming a member of the ICR can aid career development as it provides networking opportunities, discounted training, specialist interest groups and access to industry news. You can progress through the ICR membership levels but to do so you'll need to undertake a certain amount of continuing professional development (CPD) each year.

If you don't already have a postgraduate qualification, you can take a postgraduate certificate, diploma or Masters in areas such as:

• clinical pharmacology
• clinical pharmacy
• clinical research
• pharmaceutical medicine.

It's also possible to do a PhD. These courses can facilitate professional development and career advancement but you should check this against the career route you want to follow and employers of interest.

Career prospects

Career structures vary from company to company. How quickly you move up the grades depends on a range of factors including motivation, the opportunities available for training and development, ability and previous experience.

Before becoming a CRA, you may begin at a lower level such as a clinical trial administrator or junior CRA. As a CRA (also known as a CRA I), you'll work on pre-trial procedures, setting up and organising clinical trial sites (with some supervision), archiving documents and correspondence.

With the right combination of skills and experience you can move into the role of senior CRA (SCRA), also known as a CRA II. Work will include selecting investigators, coordinating ethics committee and regulatory authority applications, supervising trial supplies and attending investigator meetings.

As you progress further you'll also be responsible for supervising, training and mentoring junior staff, project management of whole trials (possibly on an international scale), protocol development and design of case report forms (CRFs). You could become a clinical team manager, clinical trial manager or clinical project manager depending on where your interests and skills lie. Beyond this are director roles within the same areas.

If you work within a contract research organisation you can build up and widen your experience with a variety of sponsor pharmaceutical companies in different therapeutic areas and in different phases of clinical research. This could allow you to move to a pharmaceutical company.

Self-employment may be possible as CRAs are employed on a freelance basis by certain companies. This should usually only be considered when you have developed experience, contacts and clients.

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Clinical Research Associate (CRA) Beginners

Training Course • CGX Training

About the CPD course

This training is a 3 day hands on and practically based course; for persons wishing to advance their career in the Clinical Research Industry. The course is specifically designed for those who wish to become a Clinical Research Associate (CRA). Delegates will gain a thorough and detailed understanding of life as a CRA. The attendees will adopt the role as a CRA and engage in conducting mock clinical trials. The course is highly interactive and utilises teaching methods and hands on practical activities based on real life scenarios.

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Clinical Research Associate (CRA) Diploma

Course Overview: Learn how to make a genuine difference in your life by taking our popular Clinical Research Associate (CRA) …

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Course Overview:

Learn how to make a genuine difference in your life by taking our popular Clinical Research Associate (CRA) Diploma Course . Our commitment to online learning and our technical experience has been put to excellent use within the content of these educational modules. By enrolling today, you can take your knowledge of Clinical Research Associate (CRA) to a whole new level and quickly reap the rewards of your study in the field you have chosen.

We are confident that you will find the skills and information that you will need to succeed in this area and excel in the eyes of others. Do not rely on substandard training or half-hearted education. Commit to the best, and we will help you reach your full potential whenever and wherever you need us.

Please note that Clinical Research Associate (CRA) provides valuable and significant theoretical training for all. However, it does not offer official qualifications for professional practice. Always check details with the appropriate authorities or management.

Learning outcomes:

• Instant access to verified and reliable information
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• Freedom to study in any location and at a pace that suits you
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By completing the training in Clinical Research Associate (CRA), you will be able to significantly demonstrate your acquired abilities and knowledge of Clinical Research Associate (CRA). This can give you an advantage in career progression, job applications, and personal mastery in this area.

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This course is designed to provide an introduction to Clinical Research Associate (CRA) and offers an excellent way to gain the vital skills and confidence to start a successful career. It also provides access to proven educational knowledge about the subject and will support those wanting to attain personal goals in this area. Full-time and part-time learners are equally supported, and the study periods are entirely customisable to your needs.

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Once you have completed all the modules in the Clinical Research Associate (CRA) course, you can assess your skills and knowledge with an optional assignment. Our expert trainers will assess your assignment and give you feedback afterwards.

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The learners have to successfully complete the assessment of this Clinical Research Associate (CRA) course to achieve the CPD accredited certificate . Digital certificates can be ordered for only £10. Learners can purchase printed hard copies inside the UK for £29, and international students can purchase printed hard copies for £39.

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The SOCRA Certified Clinical Research Professional (CCRP) program is your gateway to excellence in clinical research. Elevate your career with our internationally recognized certification, tailored for professionals dedicated to upholding the highest standards in the field. Join a community committed to ethical practices, continuous learning, and advancing global health. 

The Society of Clinical Research Associates (SOCRA) established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Those individuals so recognized may use the "Certified Clinical Research Professional" or "CCRP ®  " designation.

Path to Certification

CCRP certification is awarded upon meeting two criteria: a successful written application and a passing CCRP examination score. The benefits of obtaining certification are numerous. It not only validates knowledge, skills, and abilities but also enhances credibility and peer recognition. Career advancement and increased earning potential become tangible outcomes, reflecting a commitment to standards, compliance, and integrity.

Scope and Standards of Practice 

The standards upon which this certification program is based have been set forth by SOCRA to promote recognition and continuing excellence in the ethical conduct of clinical trials.  It is the goal of SOCRA to encourage members, and assure the competency of certified members, in their knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the ICH Guidelines, the U.S. Code of Federal Regulations, and the ethical principles that guide clinical research. Members are expected to adhere to national, state, local and provincial regulations and to international guidelines published by the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and all applicable federal, state and local laws and policies.  

Standards of Practice include an understanding of and application of basic concepts of Good Clinical (Research) Practice, including:

• The Nuremberg Code
• The Belmont Report
• The Declaration of Helsinki
• 21 U.S. Code of Federal Regulations – Parts 11, 50, 56, 312, 812
• 45 U.S. Code of Federal Regulations - Part 46
• ICH Harmonised Guideline for Good Clinical Practice E6(R2), and
• ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)
• 42 CFR Part 11 (ClinicalTrials.gov) 

Certification Exam

The SOCRA Certification Examination is offered in two formats: paper and pencil (at SOCRA sponsored sites), and computer based (at Prometric testing centers or through Home Proctoring).

SOCRA Sponsored Sites: Paper and Pencil

• Hosted exams offered in various location throughout the US and Canada.
• Visit the paper and pencil exam schedule for dates and locations.
• A complete application must be received by the deadline date as stated on the examination schedule.
• Score reports mailed to you in 4-6 weeks after exam.

Computer Based Testing: Testing Centers and Remote Proctoring 

• Offered at Prometric testing centers throughout the world or through Home Proctoring 
• Click here  for a list of test centers.
• Allow 2-4 weeks for application processing. 
• Once application is approved, schedule exam at a testing center.  Exam sessions are available at least 6 weeks in advance.  
• Score reports received immediately upon completion of exam. 

Candidate Handbook

For more information, please view the  Candidate Handbook.

Certification

• CCRP Certification Quick Facts
• Definition of a Clinical Research Professional
• Certification Program Policies
• Removal of CCRP® Credential
• Verify Certification
• Exam Overview
• Candidate Eligibility
• Application and Fee
• Computer Based Testing Exams
• Paper and Pencil Exams
• Refunds, Rescheduling and Retesting
• SOCRA Sponsored Exam Schedule
• Preparing for the Exam
• Preparation Resources
• Examination Results
• Host an Exam at Your Site
• Apply Online
• Exam Schedule SOCRA Sponsored Sites
• Requirements for Maintaining Certification
• Continuing Education Requirements
• Descriptions of Acceptable CE
• CE Recordkeeping Requirements
• Request for SOCRA CE for Courses / Workshops
• Installment Plan Payment
• Renewal of Certification
• Recertification Audit
• Recertification Learning Module
• Accreditation

Summary of Certification Activities

11,145 CCRPs (as of 12/31/2022)

• 1,391 candidates took CCRP exam
• 73% passed CCRP exam
• 2,649 CCRPs recertified
• 946 candidates took CCRP exam
• 65% passed CCRP exam
• 2,783 CCRPs recertified
• 2,060 candidates took CCRP exam
• 70% passed CCRP exam
• 3,801 CCRPs recertified
• 1,980 candidates took CCRP exam
• 71% passed CCRP exam
• 3,188 CCRPs recertified
• 104 exam sites hosted
• 2,175 candidates took CCRP exam
• 2,491 CCRPs recertified
• 91 exam sites hosted
• 2,141 candidates took CCRP exam
• 2,421CCRPs recertified

33RD ANNUAL CONFERENCE

ACHIEVING EXCELLENCE IN CLINICAL RESEARCH :

FORGING STRATEGIC COLLABORATIONS

September 27 to 29

COUNTDOWN TO ANNUAL CONFERENCE

Join us for expert-led sessions, interactive workshops, a peer-driven poster program, an engaging exhibit program and unparalleled networking opportunities!

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Clinical Research Associate Diploma - CPD Certified

Cpd certified | 25-in-1 bundle | basic to advanced | free pdf & hardcopy certificate | exam & tutor support included.

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24 Hour Flash Deal **25-in-1 Clinical Research Associate Diploma Mega Bundle**

►►► Clinical Research Associate Diploma Enrolment Gifts ◄◄◄ **FREE PDF Certificate**FREE PDF Transcript ** FREE Exam** FREE Student ID ** Lifetime Access **FREE Enrolment Letter **

Take the initial steps toward a successful long-term career by studying the Clinical Research Associate Diploma package online with Studyhub through our online learning platform. The Clinical Research Associate Diploma bundle can help you improve your CV, wow potential employers, and differentiate yourself from the mass.

This Clinical Research Associate Diploma course provides complete 360-degree training on Clinical Research Associate Diploma. You’ll get not one, not two, not three, but twenty-five Clinical Research Associate Diploma courses included in this course. Plus Studyhub’s signature Forever Access is given as always, meaning these Clinical Research Associate Diploma courses are yours for as long as you want them once you enrol in this course

This Clinical Research Associate Diploma Bundle consists the following career oriented courses:

• Course 01: Clinical Research Administration: Navigating the Healthcare Landscape
• Course 02: Research in Adult Care
• Course 03: Anatomy and Physiology of Human Body
• Course 04: Biochemistry
• Course 05: Clinical Pharmacy Certificate Program and Professional Standards
• Course 06: Health Economics and Health Technology Assessment
• Course 07: Human Anatomy, Physiology and Medical Terminology Diploma
• Course 08: Infection Control & Medicine Handling
• Course 09: International Healthcare Policy
• Course 10: Medical & Clinical Administrator
• Course 11: Medical coding Training
• Course 12: Medical Law
• Course 13: Medical Receptionist
• Course 14: Medical Teaching
• Course 15: Medical Transcription Diploma
• Course 16: Mental Health and Psychiatry Training
• Course 17: Molecular Genetics: Unraveling the Secrets of DNA
• Course 18: Neurology, Neurological Assessments & Medication
• Course 19: Nurse Prescribing and Medicine Management
• Course 20: Pharmacology Diploma
• Course 21: Public Health
• Course 22: Radiography
• Course 23: Understanding the Immune System
• Course 24: Medical Writing
• Course 25: Effective Communication Skills Diploma

Certificates Certificates

Cpd accredited certificate.

Digital certificate - Included

• CPD Accredited e-Certificate - Free
• CPD Accredited Hardcopy Certificate - Free
• Enrolment Letter - Free
• Student ID Card - Free

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Description Description

The Clinical Research Associate Diploma course has been prepared by focusing largely on Clinical Research Associate Diploma career readiness. It has been designed by our Clinical Research Associate Diploma specialists in a manner that you will be likely to find yourself head and shoulders above the others. For better learning, one to one assistance will also be provided if it’s required by any learners.

The Clinical Research Associate Diploma Bundle is one of the most prestigious training offered at StudyHub and is highly valued by employers for good reason. This Clinical Research Associate Diploma bundle course has been created with twenty-five premium courses to provide our learners with the best learning experience possible to increase their understanding of their chosen field.

This Clinical Research Associate Diploma Course, like every one of Study Hub's courses, is meticulously developed and well researched. Every one of the topics is divided into Clinical Research Associate Diploma Elementary modules, allowing our students to grasp each lesson quickly.

The Clinical Research Associate Diploma course is self-paced and can be taken from the comfort of your home, office, or on the go! With our Student ID card you will get discounts on things like music, food, travel and clothes etc.

In this exclusive Clinical Research Associate Diploma bundle, you really hit the jackpot. Here’s what you get:

• Step by step Clinical Research Associate Diploma lessons
• One to one assistance from Clinical Research Associate Diplomaprofessionals if you need it
• Innovative exams to test your knowledge after the Clinical Research Associate Diplomacourse
• 24/7 customer support should you encounter any hiccups
• Top-class learning portal
• Unlimited lifetime access to all twenty-five Clinical Research Associate Diploma courses
• Digital Certificate, Transcript and student ID are all included in the price
• PDF certificate immediately after passing
• Original copies of your Clinical Research Associate Diploma certificate and transcript on the next working day
• Easily learn the Clinical Research Associate Diploma skills and knowledge you want from the comfort of your home

Who is this course for? Who is this course for?

This Clinical Research Associate Diploma training is suitable for —

• Recent graduates
• Job Seekers
• Individuals who are already employed in the relevant sectors and wish to enhance their knowledge and expertise in Clinical Research Associate Diploma

Requirements Requirements

To participate in this Clinical Research Associate Diploma course, all you need is —

• A smart device
• A secure internet connection
• And a keen interest in Clinical Research Associate Diploma

Career path Career path

You will be able to kickstart your Clinical Research Associate Diploma career because this course includes various courses as a bonus. This Clinical Research Associate Diploma is an excellent opportunity for you to learn multiple skills from the convenience of your own home and explore Clinical Research Associate Diploma career opportunities.

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Clinical Research Associate

Clinical Research Associate Certification

Demo Clinical Research Associate Certification

CRA Training

CCRPS CRA Graduates obtained many job roles including:

Clinical Research Associate, Clinical Trial Monitor II, Research Associate, CRA II, Scientist, Quality Assurance Analyst, Senior Clinical Research Associate, Research Associate in Discovery Immunology, Clinical Trial Monitor/CRA, Clinical Trials Project Manager, Associate Director of Research Nursing, Clinical Trial Navigator, Clinical Director for R&D, Senior Clinical Research Associate, Clinical Research Professional, Medical Science Liaison, Clinical Trial Associate III, Quality Assurance Associate II, IRB/SRC Analyst II, Project Manager, Clinical Trial Associate, Clinical Research Coordinator, Public Health Advisor, Associate Scientist II, Strategy Analyst, Clinical Research Associate II, Clinical Operations Specialist, Advisor - Development Clinical Research Scientist, Neuroscience, Associate Clinical Engineer, Clinical Trial Management Associate, Quality Supervisor, Clinical Research Data Coordinator (2024 CCRPS Graduate LinkedIn Survey).

Clinical Research Associate Training

Advanced clinical research associate certification (acrac), introduction.

CME Handout

Common Terminology Used In Clinical Research - Reference Glossary

Commonly Used Abbreviations and Terms in Clinical Research

Roles and Relationships in Clinical Trials

Duties and Responsibilities of a Clinical Research Associate (CRA, Monitor)

Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

Communication between Blinded and Unblinded Staff

Contract Research Organizations (Delegation, Responsibilities, Management )

Sponsor and Investigator Roles

ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

Clinical Trial Design

Advanced Designs of Clinical Trials

Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

Blinding and Unblinding in Clinical Trials

ICH GCP - Overview

An Introduction to Clinical Research

An Overview of ICH GCP

ICH GCP - Ethical Research in Vulnerable Populations

Ethics of Research Involving Children

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Prisoners

Ethics of Research Involving Pregnant Women and Fetuses

Adverse Events

Advanced Review of Adverse Events

Clinical Trial Protocol

The Clinical Trial Protocol - Advanced Mastery Review

Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

Protocol Deviations and Violations

Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

IRB and DSMB

Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

Data Safety Monitoring board- DSMB

Review Questions

REVIEW: Review Questions for ICH GCP (for study purposes, not graded)

Site Monitoring Visits

Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

Site Qualification Visit (SQV)

Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

Site Initiation Visit (SIV)

Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"

Routine Monitoring Visit (RMV)

Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)

Site Close-Out Visit (SCOV)

Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)

Tools for Monitoring Visits

Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)

Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)

Audit and Inspections

Audits and Inspections in Clinical Trials

FDA Bioresearch Monitoring Program (BIMO)

FDA Warning Letter

Audits and Inspection Review Questions (for study purposes, not graded)

REVIEW A: Quality Monitoring Review Questions (for study purposes, not graded)

SDV and Informed Consent

ICH GCP Section 4.8 Informed Consent

Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)

Minimizing Source Data Queries In Clinical Trials

Case Report Form

Guidelines for Designing and Completing Case Report Forms

Do’s and Don’ts of a Case Report Form Design

Quality Control and Safety

Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)

ICH GCP - Safety of Human Subjects in Clinical Research

Technology in Trials (IVRS, CTMS, EDC)

ICH GCP - Trial Management, Data Handling, and Record Keeping

Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)

Clinical Trial Management System-CTMS

Electronic Data Capture and Remote Data Capture Basics

Electronic Regulatory Submission and Review

Modernized Monitoring (Remote, Risk-based, Centralized)

An Overview of Remote Monitoring - COVID-19 Update

Remote Monitoring of Clinical Trials and EMRs

Centralized Monitoring

Pharmacovigilance and Regulatory Affairs

Advanced Practice of Pharmacovigilance

Regulatory Affairs for Clinical Trials

Investigational Product

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Local and Central Labs

Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)

REVIEW PART B: Quality Monitoring Review Questions (for study purposes, not graded)

Regulatory Documents

Regulatory Documents in Clinical Trials

Delegation of Authority Log – DOAL

Investigators Brochure (IB)

CFR 21 Part 11 - Electronic Signatures

Code of Federal Regulations

CFR 21 Part 11

New Drug Application

The Investigational New Drug (IND) & New Drug Application (NDA) Process

Investigator Initiated Multi-Center Trials

IND and IDE AE Reporting

Safety Reporting Requirements for Sponsor Investigators of An IND

Trial Master File

Essential Regulatory Documents Binder Tab Organization (Trial Master File)

Trial Master File Reference Guide

Regulatory Training Quiz

Disclosures and Payments for PI, Site, Patients

Financial Disclosure- Duties and Strategies for Clinical Studies

Payments and Budgeting for Investigators and Site

Advertisement Aid in Subject Recruitment and Retention

Patient Recruitment, Retention, and Compliance

Patient Recruitment in Clinical Trials

Patient Engagement and Retention in Clinical Trials

Patient Adherence and Compliance in Clinical Trials

Misconduct and Fraud

Scientific Misconduct and Fraud

Detecting Falsification

REVIEW PART C: Quality Monitoring Review Questions (for study purposes, not graded)

Site Visit Templates

SQV Checklist

SQV Questionnaire

SQV Assessment

SQV Follow Up Letter

SIV Confirmation Letter

RMV Confirmation Letter/Fax

RMV Follow Up Letter

CRA TRANSITION Letter/Email/Fax

SCOV Confirmation Letter

SCOV Agenda

SCOV Report

SCOV Follow Up Letter

REFERENCE Module

Final Examination

Competency Exam

Start Today

• Monitor Trial Sites
• Preferred 4 Year Science Degree or RN License or Prior CRC
• Salary $60-120k+. High promotion rate.

View CCRPS Clinical Research Associate Graduate Case Studies April 2024

Enjoyed Clinical Research Training through Examples  “The real-world examples used throughout the course were incredibly useful for applying theory to practice.”  -Marta Marszalek  ( view full case study )

Case Summary:  Marta Marszalek completed the  CRA certification course seeking to deepen her theoretical knowledge and practical skills in clinical research to complement her monitoring activities and comply with industry standards.  Marta appreciated the self-assessment opportunities, which helped identify areas that needed review. Adding the certification to her CV and LinkedIn profile significantly increased her marketability and helped secure new job opportunities,  affirming the practical benefits of the course. 

From International CRC to U.S. Lead CRC and CRA:   “The flexible online format allowed me to balance my studies with my professional commitments seamlessly.” -  Aishwarya Sukumar  ( view full case study )

Case Summary:   Aishwarya Sukumar completed the CCRPS CRA certification course to enhance her understanding of FDA regulations and adapt to the clinical trials industry in the United States after relocating from abroad.   Chose the CCRPS program for its  affordability and flexibility , crucial as she was adjusting to new motherhood and transitioning careers in a new country . Successfully transitioned from a CRC to a Lead CRC, and then to a CRA role , underscoring the significant career advancement facilitated by the course.  The course facilitated a  smooth transition into the clinical research field in the U.S. , providing her with necessary certifications and boosting her credibility in job interviews.

  From IMG to securing roles as a CRC, CRA, and now a project manager:  “Joining this course was a pivotal step in my career advancement.”  - Dr. Vrushali Borawak  ( view full case study )

Case Summary:   Dr. Borawake successfully transitioned from medicine in India to clinical research in Germany, attributing significant career advancements to the CCRPS CRA training.  She secured positions as a Clinical Research Associate (CRA), and has recently advanced to a Project Manager role.  The courses  provided her with essential knowledge and confidence, particularly in job interviews , by familiarizing her with industry-specific terminology and documentation. Dr. Borawake highlighted the c ourse's effectiveness for international medical professionals  seeking to enter the clinical research field in Germany or other countries, noting its comprehensive coverage of relevant regulations and practical applications .

From Masters in Health Safety to Clinical Research Associate:   " I will say quality of delivery, quality of the materials.   - Ossai Opene  ( view full case study )

Case Summary:  Ossai appreciated the straightforward,  easy-to-follow video presentations  and found the sample questions at the end of each module particularly useful for reinforcing learning.  He found the roles and connections between CROs and CPIs most engaging and informative, providing  clear insights into the clinical research operation landscape . Ossai would recommend the course based on the quality of materials, self-paced format, and positive testimonials  from other learners. The course equipped Ossai with the necessary skills and knowledge to transition into clinical research, enhancing his understanding of industry standards and practices.

From Grant Program Manager to Leading Clinical Trials at UCSF :  "it really did a great job of the full scope of clinical research from start to finish. Since completing the course, I've received a promotion at work. "  -Hannah Fischer  (view HF clinical research training case study)

Case Summary:   Before CCRPS, Hannah Fischer Was A Grant Manager having difficulties with Clinical Trial Coordination . After CCRPS She Elevated to Clinical Trial Leader at UCSF, Excelling in Trial Management and Grant Applications. T he certification and the knowledge gained from  the course played a crucial role in Hannah securing a promotion at work , illustrating the career enhancement potential of the program. The content was comprehensive and directly applicable to her current role in managing clinical trials, significantly aiding her daily responsibilities and strategic approach.  Hannah  actively recommended the CCRPS program to her colleagues, emphasizing its thorough approach to explaining the clinical trial process from start to finish.  Her endorsements highlight the program’s applicability and value across her professional network.

Enroll Schedule Advising

CCRPS Reviews

Cra certification, detailed information, oladipo owoyomi.

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, hi...

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, highly inspiring. I recommend it for anyone with a research drive.

Lifechanging for my career

Latoya munroe.

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experienc...

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experience as I was introduced to Clinical Research Associate Certification. Hoping to build a career through this. Awesome experience

Amazing all inclusive course

David narouz.

The test was ever hard, I have studied and passed the CRA in 1 month of intensive study and would encourage anyone to take it.

Extremely well presented CRA course!

Abiodun babayeju.

This course is detailed, well presented, and provides all you need to become a confident CRA!

Fantastic tool to expand my CV

Marquise jeffery, kenny adazie, my thoughts, tondor cleopatra uzosike.

A very educative Course. Highly recommended

It is an excellent presentation with good speed in clear...

Cynthia zhao, patient recruiting and retaining, lynda agboola.

not too long but precise

Phd In Monitoring

Adriana paz mancia.

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to ...

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to life through discovery and application. So many topics are covered almost like a bootcamp for phd in trials.This is helpful

Subhash Soni

Good to understand, temitope oshineye, accelerated, zehra abbas.

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with histo...

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with history background and by other as well with thehelo of the slides.

a fundamental stepping stone for all monitors

George grudziak.

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn ...

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn what is covered in just a chapter. I refer back to the course every time I switch to a new trial to refresh my knowledge.

Mary Dahodu

Great course with high knowledge impaction. Platform also was easy to navigate.

Dedication to real material

Asra feroze.

The diligence and direction provided by this course material has inspired my inner confidence to climb high to reach the pinnacle of my ambitions.

Refreshed my knowledge after 10 years in monitoring

Dr. sharib syed muhammad.

Best refresher for clinical researchers. A lot of content but can skim modules if you know them well.

CCRPS trains monitors to succeed in remote and local site...

Esohe ayanru.

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to m...

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to move up. This course was so advanced and really made sure you understood all the core guidelines and monitoring report processes. It made me feel much more comfortable when applying for new jobs.

two weeks to update your resume

Shivani dhotre.

CRA training took me about 2 weeks straight. I learned a lot and videos were very refreshing. It was noticed by recruiters on resume.

A great review of clinical research for monitors

Jayant shrivastava.

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lo...

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lots of templates in each module for SIV and other things which I really liked.

Learn by examples. Great follow through videos.

Abiodun adegbite.

Exceptional information not found anywhere else. Everything has an example. Content just makes sense as dry as reviewing protocols and guidelines can be.

Remarkabley accurate lectures that go into so many reason...

Vaishnav nath ajeendra nath.

This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quit...

This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quite a lot of foundation and practical skills. This was an absolute wonderful learning experience on this platform, thanks for the assistance and hope to continue to learn from this experience, thank you...

ACRA Training

Ossai a opene.

Great class and easy to follow. The materials are sequential and great review questions. I strongly recommend the training to any one that wants to get int...

Great class and easy to follow. The materials are sequential and great review questions. I strongly recommend the training to any one that wants to get into the CRA space.

Gertrude Nenanya

Detailed and Informative. A lot to take in yet rich with step-by-step information to prepare anyone new to clinical research

clinical research associate

Khalel imanbayev, sathya ramamoorthy, best way to start a new career as an img.

I decided to switch careers shortly after finishing my bachelors and was recommended to look into clinical trials. This program was essential in my career ch...

I decided to switch careers shortly after finishing my bachelors and was recommended to look into clinical trials. This program was essential in my career change and honestly everything made sense so I felt like I really understand and enjoyed the material! You don’t need a science background to take this.

Knowledgeable

Norah okafor.

It has really been of great impact with my 5 years experience as a CRC.

Very good content

Great course for updating information and knowledge

Mohammad ismail, dr. jennifer campbell-allman, dr. jennifer campbell-allman, phd. msc., rmhci., very detailed information, goliath sakala.

This course is very detailed and informative.

Only resource CRAs need

Husnain arshad.

Very interesting and useful for CRA training

Advance Clinical Research Associate

Charity oparah, acrac review, cyprian suh.

Very, very enriching; content and presentation.

It is informative

Safeyeh alghazali, adeyinka balogun agesin, its a great opportunity for me to review again all aspect..., adam friday.

EXCELLENT EXPERIENCE

Loving my training!

Corinthia mims.

I really appreciate the ability to return to a section to observe again. I like being able to take my time to learn.

Sergiy Ivashchenko

Very Good Course

CRA Training Program

CRAs monitor clinical trial sites for compliance with guidelines and protocols. Salary of $60k to 120k+ based on experience level.

Requirement

A minimum of 4 year degree in science required though scientists, IMGs, nurses, prior coordinators, and even senior CRAs take our course.

Takes 2-4 weeks. Start today. Self-paced. 3k+ enrollees choose us because of our advanced curriculum with practice applications and competitive pricing.

Certification

Triple-accredited course with 17.5 CME. Achieve 70% on 2 attempts on MCQ exam.

How to become a clinical research associate

To become a clinical research associate, you must first complete an accredited clinical research associate training program. The course provides an extensive review of the regulations and principles of clinical research, as well as practical application of the skills needed to execute and manage trials correctly.

Clinical research associate certification test covers topics like clinical research protocols, FDA regulations, Good Clinical Practice (GCP), ICH guidelines, data management and more. If you pass the exam, it means you're certified as a CRA.

You can get clinical research associate training online free with webinars, tutorials, eBooks and other materials related to the profession. This can help you learn more about the job before you get certified.

What is a clinical research associate

A CRA makes sure clinical trials are done correctly and on time. They make sure the clinical trial follows the plan, good clinical practice guidelines, ethics, and laws. CRA's must know a lot about trial protocols, patient safety, data integrity and regulatory requirements to guarantee the quality of a clinical trial.

Clinical Trial Associate

A clinical research monitor will review study sites' data collection processes to ensure that all data collected is complete and accurate. This includes conducting on-site visits to assess study sites' compliance with good clinical practices (GCP), review case report forms (CRF), and periodically audit research sites to ensure compliance.

Clinical Trial Monitoring

Clinical research associates do things like teach the protocol; talk to human subjects and their families; get ready for investigator meetings, trainings, documentations; manage study supplies inventory; track subject enrollment, visits, data reports, study timelines; and solve any problems that come up during the study.

Why get clinical research associate training

Clinical trial monitoring job growth.

Getting certified as a Clinical Research Associate (CRA) gives you the opportunity to start earning salaries of up to $100,000 and 33% of new CRAs receive promotions within the first year.

Clinical research association accreditation

The ACRAC training program is internationally accredited by industry standards including IAOCR, ACCRE, AMA, ACPE, ANCC to provide comprehensive training for those holding at least a BA in Science.

Fast track clinical research training

Flexible online training and on-demand video modules that can be completed in as little as 2 weeks for a clinical research associate fast track career.

Clinical Research Associate Salary

Salary for clinical research associate

Clinical research associate salary (CRA) is typically higher than the national average and varies depending on experience, job title, city of employment and industry. The average annual salary for a CRA was estimated to be $80,000 in 2024.

Entry-level clinical research associate salaries can range from $47,000 - $80,000 per year. As a CRA gains more experience and furthers their education, they may be able to negotiate higher salaries due to their valuable knowledge and skills.

can exceed $90,000 in certain geographies or with specialized skillsets. Generally speaking, the higher the level of education or specific certifications held by a CRA, the higher salary they can expect to earn.

Various factors impact how much a CRA can earn such as their employer’s size and industry sector (pharmaceuticals vs biotechnology companies), amount of travel required for research responsibilities and tasks assigned.

Clinical research associate job description

What does a clinical research associate do

Developing Protocols and Case Report Forms

The Clinical Research Associate is responsible for creating clinical research protocols and Case Report Forms. This includes writing instructions, outlining procedures, collecting data, assessing collected samples/specimens, and making sure people follow the protocol/investigational plan.

Monitoring Clinical Study Sites and Teams

The CRA role includes making sure that sites are monitored, data is accurate, and reviewing source documents. They also manage a team of physicians, nurses, support staff (if applicable), vendors (such as laboratories) involved in the clinical trial and providing training on protocol requirements in order to achieve successful outcomes from each trial/study conducted.

Ensuring Regulatory Compliance

CRAs need to make sure they follow all the rules and regulations for conducting studies. This includes making sure the studies are safe for patients, ethical, and accurate. CRAs also need to attend regular meetings with people who are involved with the study to discuss any changes in the rules or regulations that could affect how the study is conducted.

Clinical Research Associate Jobs

How to obtain a CRA job

Utilize online job boards, such as Indeed and Glassdoor, to search for open positions. When searching, use keywords such as "clinical research associate jobs", "clinical research associate job", "clinical research associate jobs entry level" and "remote clinical research associate jobs". Make sure to write a cover letter.

To find potential employers as a Clinical Research Associate, look in directories of medical companies or local businesses.Contact the employer by email or phone and tell them why you would be good for the job they are trying to fill.

Talk to people who have jobs like the one you want, follow professional organizations on LinkedIn, and go to events where you can meet these people. This way, you might hear about job openings.

Check social media for job postings by following accounts related to Clinical Research Associates and checking them regularly for new postings that might be a good fit for you.

Clinical Research Associate Certification FAQs

Clinical research associates (CRAs) are professionals who work in the pharmaceutical and healthcare industries to manage clinical trials and collect evidence. The primary role of a CRA is to ensure that all clinical trials and research studies are conducted according to legal requirements, ethical standards, and good clinical practices. CRAs interact with other healthcare professionals, researchers, patients, and sponsors to coordinate activities related to the trial. A successful CRA must have a strong background in science and medicine, as well as solid communication skills. Candidates for CRA jobs typically undergo training on Good Clinical Practices (GCP) prior to beginning their job duties. Clinical research associate roles include but are not limited to recruiting subjects for studies; designing protocols; performing administrative tasks such as budgeting; coordinating data collection; providing feedback on documents; conducting site visits; monitoring safety reports; reviewing patient records; preparing reports; analyzing data from clinical trials; maintaining records of trial progress; managing study databases; and developing clinical trial databases.

1) Spearhead the planning, implementation and evaluation of clinical studies by preparing study protocols, developing case report forms and managing data collection. This includes creating regulatory documents such as informed consent forms, patient diaries and Investigator's Brochures. 2) Monitor study progress with sites to ensure compliance with protocol requirements and regulations, such as Good Clinical Practice (GCP). Review raw data, verify accuracy and completeness of case report forms, analyze data using statistical software packages and participate in final report preparation. 3) Participate in the selection of sites for trials while maintaining professional working relationships with investigators. Generate metrics from study results and attend investigator meetings to provide target product profiles/project plans that align with organizational objectives.

1) Prepare study documents such as protocols, informed consent forms, case report forms and investigator brochures 2) Monitor sites to ensure compliance with study objectives, protocol requirements, good clinical practices (GCPs) and applicable governmental regulations 3) Ensure the accuracy of subject enrollment, data collection and handling processes 4) Oversee the maintenance of accurate source documents and regulatory binders 5) Manage investigator payments according to contract terms 6) Train site personnel on protocol and GCPs requirements 7) Track necessary regulatory documents such as licensure/DEA/IRB approvals; resolve any related issues with IRBs or other regulatory agencies. 8) Lead study start up activities including sending out essential materials to sites, distributing and completing required training for staff members; verifying that site initiation visits are completed timely 9) Prepare monitoring plans in consultation with the sponsor or CRO leadership; perform pre-study, initiation, interim and closeout visits at investigative sites as per study timelines. 10) Perform remote monitoring activities by regularly reviewing case report forms (CRFs), checking query log resolution status from sites. 11) Provide guidance on data entry queries from clinical research coordinators (CRCs) or other site personnel. 12) Monitor safety events reported by sites; notify appropriate parties promptly regarding serious safety events or protocol deviations. 13) Ensure that all adverse event reports are followed up for completion by review of medical records. 14) Generate routine visit reports using standard CRF formats; track budgets for each site according to protocol specific requirements & perform final reconciliation of monies within sponsor's payment system.

1) In order to become a Certified Clinical Research Associate (CRA) with CCRPS CRA certification, the first step is to research and obtain an undergraduate degree in any field related to clinical research, such as public health, healthcare administration or epidemiology. 2) Prospective CRAs should strive to gain experience in a clinical research setting through volunteer positions or internships within hospitals, clinics, universities or pharmaceutical companies. 3) The next step is to take and successfully pass the Certified Clinical Research Associate (CRA) exam offered through the Certified Clinical Research Professional Society (CCRPS). This comprehensive examination covers topics such as Good Clinical Practice (GCP), study design and implementation, regulatory compliance and ethics.

•CCRAs have a more standardized set of skills, which can help with advancing their career and obtaining higher salaries. • Becoming a CCRA provides greater opportunities for job advancement and the potential to improve salary. • Additionally, CCRA certification is a great way to demonstrate expertise, stay on top of industry developments, network within the field, and have access to exclusive resources.

1) Become an expert in clinical research studies. Take the time to learn as much as possible about different types of trials, protocols and procedures, as well as the regulations governing clinical research. Additionally, take advantage of any available continuing education opportunities and seminars to stay up-to-date on the latest developments in the field. 2) Develop strong organizational skills to effectively manage multiple studies, sites and deadlines. Create a system for tracking tasks and deliverables so that nothing falls through the cracks – this will keep sites, sponsors and investigators happy and maintain your reputation for excellence. 3) Establish yourself as a reliable source for knowledge both inside and outside your organization. Keep abreast of current trends in the industry so you can offer advice to others or answer their questions promptly; gain recognition by authoring publications or presenting at industry events; and always make sure your work is accurate and follows all applicable regulations.

1. PRA Health Sciences: A global biopharmaceutical organization that provides contract research services and drug development solutions to pharmaceutical, biotechnology, and medical device companies. 2. Syneos Health: A clinical services organization delivering integrated, tailored solutions to help customers accelerate the delivery of therapies to market with confidence. 3. IQVIA: A leading provider of integrated information and technology solutions for healthcare and life sciences organizations, helping them drive efficiency and effectiveness across all aspects of their business. 4. ICON Clinical Research: Providing strategic development advice and clinical trial execution services from a network of highly qualified site personnel across 63 countries. 5. Covance: A contract research organization (CRO) providing drug development solutions from laboratory testing services through to large-scale clinical trials in more than 25 countries worldwide 6. Chiltern International Ltd.: An award-winning CRO that offers full-service clinical development capabilities such as legal compliance support, project management, medical writing, data management/statistical analysis, safety/pharmacovigilance monitoring and global regulatory submissions assistance for clients in the US, Europe, Asia Pacific, South Africa and Latin America. 7. BioClinica Clinical Trials Solutions: Offering comprehensive eClinical suite that helps streamline processes related to study design, document management & reporting as well as imaging & safety data collection & review process management in real time around the globe for all types of studies—Sponsor-initiated Protocols (SIPs) or Investigator Initiated Studies (IIS). 8. Worldwide Clinical Trials: An award-winning CRO providing comprehensive clinical trial operations & data management services from initial concept development through final report generation across multiple therapeutic areas including oncology & rare diseases for both early phase studies & late phase trials in over 28 countries around the globe. 9. Clinipace Worldwide Clinical Trials Services: Specializing in creating innovative technology platforms for clinical research by combining its expertise in digital media with its deep understanding of regulatory policies thereby helping reduce complexities associated with managing large scale global projects involving multiple stakeholders from different parts of the world from start to finish – protocol design & buildout; patient enrollment & retention; site training; EDC builds; study closeout activities etc., involving both electronic data capture (EDC) based studies as well as non EDC based studies which can be delivered simultaneously or independently depending upon customer's requirements/goals at any one given point in time during the life cycle of a clinical trial project globally - US/EU/ROW markets etc., while adhering to the highest standards of quality assurance (QA), timelines and budget requirements resulting into improved operational efficiencies on part of our customers leading to better ROI figures towards end results achieved by successful completion of projects within stipulated timelines without compromising on Quality whatsoever!

1. Clinical research associates typically make an average of $53,000 a year, with a range between $45,000 to $62,000 annually. 2. The top 10 percent of clinical research associates can expect to make around $70,000 or more annually. 3. The lowest 10 percent of clinical research associates earn around $40,000 or less per year. 4. Mid-level salaries for clinical research associates usually fall within the range of $50,000 to $60,000 annually. 5. Incentives such as bonuses and commissions can significantly increase overall earnings for experienced clinical research associates. 6. Geographical location is often a factor in determining salaries for this profession; locations that tend to pay more include states like New Jersey, California and Massachusetts as well as metropolitan areas such as Seattle and San Francisco. 7. Other factors that may influence how much a clinical research associate earns include experience level and sector of the industry they are employed in (i.e., government, private or academic). 8. A career in this field offers many opportunities for growth and financial advancement; with additional education or certifications an individual could potentially make upwards of six figures annually after several years of experience in the profession.

Clinical Research Associate Course Syllabus

The CCRPS CRA program contents meets AMA requirements for 17.5 CME. This means that the course can help you succeed in your medical career. Additionally, the introductory chapter introduces you to clinical terminology and abbreviations commonly encountered in clinical research.

As a clinical research associate (CRA), it is important to know how to interact with other stakeholders in order to set up and monitor clinical trials for an investigational product or IP. These stakeholders include the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC), other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

The ICH-GCP guidelines provide procedures and precautions for protecting human research participants during clinical research. These guidelines cover obtaining informed consent from human subjects, maintaining trial records, reporting compliance and progress, as well as procedures for suspending or terminating trials. The chapter also covers the importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

This chapter will teach you about the different phases of clinical trials, from the pre-clinical phase to Phases 0-4. You will learn about important concepts like the structure and goals of each phase, dosing approaches, toxicology testing, and more. The chapter will also review the FDA's drug approval process.

The chapter provides an overview of GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

In chapter 6, we will learn about ethical research involving vulnerable populations. This includes people who are pregnant, children, mentally incapacitated individuals, and prisoners. We will learn about the challenges of conducting research with these groups of people, including obtaining consent from parents or guardians, providing fair incentives, and using deception or incomplete disclosure in a justified way.

This chapter covers the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects.

Chapter 8 is all about clinical trial protocols (CTPs). This chapter goes into detail about what a CTP is and how to write one. It also covers important concepts like study risk benefit analysis (RBA), sample size and statistical power, data analysis, risk management, and study administration. Additionally, the chapter addresses concepts related to choosing participants for the study, including inclusion and exclusion criteria, safety concerns, and ethical considerations.

This chapter will teach you about protocol deviations and violations. You will learn about the different types of deviations and violations, and how to distinguish between them. You will also learn about the most common violations, including minor ones (like off-schedule subject assessments) and major ones (like failure to report AEs). Finally, the chapter will review principles for reporting protocol deviations and IRB approval for planned deviations.

The IRB (Institutional Review Board) and DSMB (Data Safety Monitoring Board) are responsible for reviewing and approving research studies involving human subjects. This chapter reviews the history of these boards, and discusses the principles that guide their decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.

This module provides an overview of different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

This chapter provides a thorough understanding of the stages and steps involved in selecting a study site. The module reviews elements such as the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). It is important to learn about the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.

This module goes into detail about site initiation visits (SIVs). You will learn how to prepare for an SIV, including what approvals, permits, and licenses you need. Additionally, the module covers what should be on the SIV agenda, such as orientation and training for site staff. Finally, you will learn about post-SIV procedures, such as filing compliance documents like FDA form 1572 and Financial Disclosure Form (FDF).

This unit will teach you about routine or periodic monitoring visits. You will learn about the agenda of an RMV, which includes receiving updates on AEs from site staff and overseeing the progress of trials. The unit covers different approaches to site monitoring, including traditional (full-scale) monitoring and risk-based monitoring (RBM). It also compares on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is essential for obtaining accurate data from clinical trials.

This chapter covers everything you need to know about ending or finishing a trial site. This includes things like notifying the IRB and coordinating schedules among site staff (PI, other investigators, medical staff) and the monitoring team (CRC, CRAs, etc.), as well as preparing for an SCOV meeting – drug inventory management, database verification and lockdown, subject notification and completion of all subject-related documents, staff-related documentation, and other administrative tasks like compiling a close-out report.

This unit provides tips and tools to help a CRA (clinical research associate) effectively monitor clinical trials. The chapter lists physical accessories that can be useful for monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions.

This module will help you understand and prepare for audits and inspections by the CRO, FDA, or other regulatory authority. It covers the difference between an audit and an inspection, and provides detailed protocols for both. Additionally, it outlines the sequence of an FDA inspection, including a walk-through of the Biomedical Research Monitoring Program inspection. You will learn about important audit and inspection documents, such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation). You will also learn about the Establishment Inspection Report (EIR) prepared by the auditor/inspector. Finally, you will understand the different types of observations in an EIR, including NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated).

This chapter discusses the ICH-GCP guidelines on obtaining informed consent from subjects. The highlights include the need to use non-technical language, transparently delineate risks, obtain consent without undue influence, obtain consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to ensure that subject trial data (as recorded in Case Report Forms or CRFs) correspond to source data (previous medical records).

This module provides a detailed overview of the structure and elements of a Case Report Form (CRF), including different forms for Principal Investigator (PI) verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events, etc. Additionally, the chapter outlines important data notation rules, such as the use of accepted acronyms (e.g., ‘ND’ for missing data and ‘UNK’ for unknown information), MM-DD-YY format, time-stamp data, etc., as well as guidelines for the design of CRFs (e.g., consistency of notation, avoidance of duplicate data fields).

In this unit, you will learn about Quality Control in clinical trials. This includes understanding what Quality Control is, its relationship with Quality Assurance, using Key Performance Indicators, having a Corrective and Preventive Action plan, and more. Additionally, the module will look at the QA process, focusing on risk-based monitoring and providing guidelines on Quality Metrics. The chapter also reviews ICH-GCP guidelines on subject safety, including risk-benefit assessment and stoppage rules in case of serious adverse events. Finally, it introduces the FDA’s Human Research Protection Program.

This tutorial provides an in-depth look at the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs), including IVRS and IWRS, as well as RTSM systems for Randomization and Trial Supply Management are examined. The benefits of standardized data management and data sharing, approaches to database management, and the concept of an Independent Data Monitoring Committee (IDMC) are reviewed. Critical elements of data integrity, such as proper anonymization and coding, completeness of data, data safety precautions, and logging of site visits and other progress reports are highlighted Essential features of a good Clinical Data Management(CDM) system that complies with FDA CFR Title 21and HIPAA regulation.

This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements.

This unit will teach you about pharmacovigilance (PV), which is the process of monitoring the effects of drugs. You will learn about the statistics on adverse events (AEs), how to distinguish between Type A and Type B AEs, and how to assess the severity and probability of an adverse drug reaction (ADR). This unit also covers Individual Case Safety Reports (ICSRs) in detail, including their structure, content, and role in trial monitoring. Other topics include types of PV inspections, periodic safety update reports (PSURs), and study criteria for instituting data safety management boards (DSMBs).

In this chapter, we provide a detailed review of the protocol for receiving, storing and dispensing the investigational product (IP). At every stage, there are guidelines in place to ensure the safety of study subjects and staff. This includes handling the IP with care, logging relevant information such as date of manufacture and batch number, and recording shipping details. Additionally, we address the need for precautions when dispensing the IP, such as limiting access to authorized personnel only.

This section looks at how lab testing in clinical trials has changed over time. It used to be done in local labs, which had a lot of mistakes. Now it is done in central labs, which makes it more accurate and reliable. The section also covers standards for clinical trial laboratories, such as the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments). Additionally, it provides guidelines for lab audits, including fire safety and staff training.

The chapter reviews essential documentation that needs to be created and maintained throughout the clinical trials. This includes the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312. You will learn about each of these forms and why it is important to keep records updated, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. The unit also requires that you submit documents that describe the procedures for the study and site, including an SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR). This includes Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56), Series on food (100), pharmaceuticals (200 and 300), as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES). Part 11 lays down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

This module will cover the process of how drugs are evaluated by the FDA, and the role of a CRA in this process. You will learn about the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The criteria for evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, you will learn about FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators.

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF.

In this chapter, we will discuss FDA guidelines regulating financial disclosure in depth. This will cover the definition of 'conflict of interest' and the stipulations of Title 21 Section 54 on disclosure requirements. We will also study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on 'fair market value' as well.

The chapter also talks about things that might make it hard to meet recruitment goals, and how to make it easier, like being less picky about who can join, giving people money to cover travel costs, and making it clear what benefits come from participating. The unit also covers why patients might leave a trial early, and how to prevent that from happening as much, like making the experience better for patients (by paying more attention to them and being flexible with when they can come in for visits, etc.), and using technology to make things simpler and more efficient (like having digital forms that can be completed automatically). Finally, the unit discusses some new ways of keeping patients involved and compliant in clinical trials; these techniques use technology to get better results.

This module discusses reasons why people might commit scientific fraud, and the consequences of fraudulent practices in clinical trials. A scale is presented for classifying errors in clinical trial data. At one end of the spectrum is ‘honest, isolated mistake’ and at the other end is ‘deliberate data falsification with malicious intent’. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will learn how to identify signs of fraud during the actual clinical trials process.

Meet our CRA Academy team and learn about our openings!

Hear what Ellari has to say about her experience in our CRA Academy Program

Clinical Research Associates (CRAs) are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. Individuals in these roles play a vital part in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and with the care and passion our patients deserve. At Worldwide, we invest in your success by offering high quality opportunities to ensure you have the tools to excel. We want to help develop the next generation of CRA talent!

Through our CRA Academy, we provide full-time training, mentoring, and hands-on experience for those new to the CRA role! Members in our full-time program will actively participate in group discussions, root cause investigations, and group assignments throughout the program. Core content will be shared via virtual, instructor-led sessions directed by one of the top industry experts in clinical research training. Self-study learning assignments are also integrated within the program, allowing for independent completion. Additionally, each student will have a mentor assigned to them to help build confidence in hands-on practice and strengthen camaraderie amongst the team.

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers. Join us in achieving our vision of becoming the World’s Best Midsized CRO!

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CCRA Certification

Ccra® (certified clinical research associate) is a credential formally recognizing clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor., this trusted mark of excellence in clinical research is awarded to clinical researchers who have demonstrated proficiency of specific knowledge and skills by passing the standardized ccra® certification exam., read the latest acrp ccra® blog, “spotlight on the clinical research associate career pathway and resources” >.

Apply for Your Exam

Clinical research professional with 3,000 hours of verifiable work experience are eligible to sit for the CCRA ® Exam. Complete eligibility criteria is defined in the Academy’s  policy manual .

What qualifies as work experience, work related to human subject research, paid contractual agreement – employer/employee, can be verified by acrp through employer, what is excluded from work experience, any work that is part of a degree track or education program, any experience older than ten years, internships paid or unpaid.

ACRP may grant one experience waiver amounting to 1,500 hours of work experience to applicants who meet one of the following criteria:

Hold an active acrp certification, have successfully completed a clinical research education program*, what qualifies as a clinical research education program*, must be aligned with the topics found in the corresponding detailed content outline (dco), must have a valid third-party accreditation, must provide applicants with knowledge that is equivalent to 1,500 hours of knowledge earned through employment, *program approval is at the discretion of acrp and will not be reviewed or pre-approved outside of a paid application..

The CCRA ® exam consists of 125 multiple choice questions that must be answered within 180 minutes.

The exam is referenced only to the international conference on harmonization (ich) guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)., the following are the only references for which the ccra ® certification exam content can be supported:, ccra ® exam detailed content outline >, guideline for good clinical practice e6 (r2) >, definitions and standards for expedited reporting (e2a) >, general considerations for clinical trials (e8) >, statistical principles for clinical trials (e9) >, clinical trials in pediatric population (e11) >, the declaration of helsinki (doh) >, the global ccra ®  exam committee uses psychometrically sound practices to develop certified clinical research associate (ccra) examinations that meet the current test specifications as determined by the most recent job task analysis (jta)..

Review the Detailed Content Outline and make sure your experience and work hours are appropriate, as outlined in the Eligibility tab.

We also strongly encourage you to review the entire acrp certification handbook , which provides full details about every facet of acrp certification..

Create a free ACRP account so you can begin the application process. Follow the on-screen prompts to enter any requested information and documentation.

If you already have an acrp account, please proceed to step three., create account >.

You’re almost there! Please note, applications selected for audit will undergo a formal review by ACRP’s subject matter experts. In most instances, you will receive a status update about your application within 10 business days.

In accordance with the americans with disabilities act, acrp will provide reasonable accommodations for candidates with disabilities. please complete this special accommodations form for submission with your application before proceeding., acrp’s testing partner psi offers in-person testing, as well as on-demand remote testing available 24 hours a day, every day, during the testing windows., watch these videos to learn what to expect from each option before scheduling your exam..

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Schedule your in-person exam >.

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Check system requirements >.

The best way to prepare for the CCRA ® exam is to fully understand the scope of the exam content and its references.

Please be sure to thoroughly review the following:, acrp certification handbook >, remember: the exam is referenced only to the international conference on harmonization guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)..

We also recommend leaning on your community! Thousands of ACRP Certified members have been in your shoes. They are active community members and always willing to share tips and advice for ACRP exam prep.

Visit the acrp community >.

ACRP offers a variety of training and continuing education programs focused on the key ICH guidelines covered in the CCRA ® exam.

Learn more >.

Exam results are shared immediately at the conclusion of your exam, but PSI will send you an email with your full score report within 24 hours.

Your acrp account will reflect your results within 24 hours..

Congratulations! You just passed a major milestone on your professional journey and are now a member of the elite club of ACRP Certified clinical research professionals.

Keep an eye on your email because you will soon receive information from our digital badging partner credly about claiming your digital badge and how you can use it to tout your accomplishment. also learn how to use your new credential by reviewing the  certification mark policy ., you have 2 years to keep your certification in good standing by continuing your professional development, and we’ll be right there with you every step of the way. in the meantime, we highly recommend you review all the details about maintenance of certification . don’t leave it to the last minute.

Don’t worry. It happens to the best of us. Give it another try!

Refer to your acrp certification examination results email or the acrp certification handbook for guidance on the next steps in your certification journey., upcoming testing dates, spring 2024 testing february 15 – may 15, 2024, fall 2024 testing july 15 – october 15, 2024, 2024  registration dates and fees, early bird registration acrp members – $435 nonmembers – $485 spring 2024:  october 15 – december 31, 2023 fall 2024:  may 15 – july 15, regular registration acrp members – $460 nonmembers – $600 spring 2024:  january 1 – april 30 fall 2024:  july 16 – september 30, join acrp & save, joining acrp helps you save money. more importantly, acrp is where you will find the very best of what you need to design a career path that’s uniquely your own. connections through an engaged community. growth through gold-standard training. and elevation through rigorous certification., explore membership >, exam preparation, congratulations on your decision to earn the most recognized and respected endorsement of clinical research competency — acrp certification. as you start this important journey in your career, we’re here to support you every step of the way..

Register Now

Once registered, we will add you to our CRA Academy list and reach out to you soon to collect your payment details. We accept credit/debit card payments only.

For more information contact:

[email protected]

Next class starts october 2024.

The only Clinical Research Academy that provides practical, real industry experience for future clinical research associates, coordinators, and dozens of other positions.

NOW OFFERING ONCOLOGY MONITORING EXPERIENCE remotely to students who successfully graduate!

Students Acceptance Per Quarter

Pedagogical Staff Support & Educational

Online Resources E-Learning, eTMF, EDC

Educators : Students Ratio (+ Surprise Guests)

Working Graduates Since 2016

NEXT QUARTERLY SESSION BEGINS THE WEEK of

October 14, 2024.

This training applies to most clinical research positions such as CRAs, study coordinators, and dozens of other industry roles! We are proud to announce that we now offer oncology experience for our internship component for students who successfully graduate. We also support full remote monitoring internship opportunities for this indication!

We help our students to:

• Understand the fundamentals of clinical research from the perspective of a generalist
• Gain industry experience after passing the 3 month online course with an optional onsite internship (exceptions apply) or remote internship which is always included
• Practical job interview preparation, job lead recommendations, and CV preparation that will make a difference.
• Unlimited support throughout your clinical research career
• Obtain Oncology as well as other therapeutic indication experience

How The Academy Is Structured

The CRA Academy is a 3 month course that has an optional and free remote internship program where students who successfully complete the three month course (score a cumulative grade of 80% or higher) will be given the opportunity to gain valuable industry experience while working on real studies.

Our academy is 100% online with weekly video modules followed by a weekly live webinar taught by one of our CRA instructors. The 1 hour webinars are held every Saturday at 1 PM PST for the duration of the academy. During the webinars, the lessons from the prior week’s module will be reviewed, questions will be answered, and homework will be assigned. We use real virtual workspaces and actual EDC systems that are used in the industry in order for students to better familiarize themselves with common industry tools.

After the 3 month academy, a final exam will be given and students must pass the exam to successfully complete the academy. During the 3 month course students will also become GCP and IATA certified. Post-academy internships will be made available for everyone who successfully completes the 3 month training.

After successfully completing the course material, students have the option of doing internship activities remotely (online), or at a site near them (exceptions apply), or a combination of the two. There is no additional fee for either of these options and we have seen that students who take advantage of these free opportunities tend to land industry positions faster.

Additionally, we are wholly owned by DSCS CRO which engages in phase 1-4 industry sponsored and investigator initiated trials. Some of our trials on clinicaltrials.gov can be found here , here , and here . Students will be given opportunities to work within our CRO on the above linked trials during the internship phase, and any student that participates in our online internship will have an opportunity to monitor an oncology project that our CRO manages. Certificates will be distributed to students who have successfully completed the coursework.

Why Be A CRA?

CRAs are always in high demand and the career can be quite rewarding. There are however, very few opportunities out there for individuals without any knowledge or industry experience. The minimum requirements for an individual to become a CRA are as follows:

• Prior industry experience is typically required in order to be a CRA (Our Academy offers real industry experience)
• Must have at least a Bachelor’s degree (foreign degrees are acceptable; degrees do not have to be science related)
• Must have a working knowledge of the fundamental principles of clinical research

Claud & Lora

Marchna & Reploly

Emanuel, Lucky & Angelica

We are a group of individuals that have been operating various clinical research sites, CROs, and consulting companies since 2005. Due to a huge demand, from many of our clients, we have decided to create The CRA Academy as a tool for not only teaching the fundamental principles of clinical research, but also to provide students with some much needed (and often required) industry experience.

Tiffany Bennett

Chris Sauber

Prior to entering the clinical research industry, I graduated from the University of Southern California in 2005 with a Bachelor’s degree in Health Promotion and Disease Prevention Studies. In 2013, I obtained a certificate in Pharmaceutical and Healthcare Business from the University of Sciences, Philadelphia.

In my career, I have worked for private practices, major pharmaceutical companies and clinical research organizations as a data manager, clinical project coordinator and clinical research associate. I was a Site Director for a physicians network for clinical trials and I currently hold the Director of Clinical Research position for the Ora Lee Smith Cancer Research Foundation (a non-profit organization aimed to eradicate solid tumor cancer cells with a laser medical device, more specifically a Laser Activated Nanotherapy Technology). I also had the opportunity to teach multiple medical doctors and over 50 pre medical students the basics of clinical research for the National Medical Association.

I have 16+ years of experience as a clinical research professional and I have helped hundreds of individuals enter the clinical research industry.

Dan has owned and operated clinical research sites since 2005 when he learned to become a clinical research coordinator on his own. Since that time, Dan has worked as a contract CRA in addition to being Site Director and a consultant to the life sciences industry.

Chris started out in clinical research as a study coordinator and quickly transitioned into a CRA, project manager, auditor, contracts and budgets specialist, site director, site owner, CRO co founder, amongst other roles that have made him an all around generalist in the industry.

Frequently Asked Questions

How long is the internship.

The internship is only available to students who pass the final exam. We typically recommend graduates spend at least 3 months for the internship phase however students may intern for as long as they need in order to gain the necessary work experience. We do not charge anything extra for the internship.

Can I do the internship remotely?

Yes. Although we recommend everyone try to intern at a research clinic near them (exceptions apply), most monitoring activities, such as source data verification and source data review, can be accomplished remotely. Furthermore, to guarantee that students gain oncology experience, they must participate in the remote internship.

Do I need to quit my job to intern?

No. We purposely limit your workload to no more than 6 hours per week and interns can make their own schedule for the most part.

Are We Accredited?

While we have been accredited in the past, we chose to not renew our accreditation due to the fact that we operate as a CRO and Site Network and employers much prefer our real study experience opportunities for our interns rather than an arbitrary accreditation.

FREE 4.5 hour comprehensive crash course of many of the topics we cover.

Have a question.

To learn more about The CRA Academy, please fill out the contact information below:

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Enrollment Cost:

$5,000 usd per student, tuition fee includes 3 month online classes, materials and internship..

We accept credit/debit card payments only. You may register now if you'd like. Fill in the fields provided on the sidebar of this website with your first name. last name, email address, and mobile number and press the “Register Now” Button.

Once registered, we will add you to our CRA Academy list and reach out to you soon to collect your payment details. We accept credit/debit card payments only

Special Circumstances:

If necessary, the class can be paid for in two installments of $2,500. The first payment is due upon registration and the second payment of $2,500 will be due during the second month of the program.

NOTE: A BACHELOR'S DEGREE IS REQUIRED TO BE EMPLOYED IN THE RESEARCH INDUSTRY AS A CRA

Cancellation policy.

Once access to the course has been granted, there will be no refunds. If a student for some reason is unable to complete the quarter, we can make arrangements to place them in the following quarter's class.

"The CRA Academy" is owned and operated by DSCS Sweat Equity & Investments, LLC & The Clinical Trials Guru, LLC

T: (949) 415-6256 | E: [email protected]

1830 Commercenter East San Bernardino, CA 92408