Clinical Research Associate
Clinical Research Associate Certification
Clinical research associate certificate will help you get hired or promoted in clinical research monitoring jobs. Gain knowledge to be successful with advanced clinical research associate training. Join one of the best clinical research associate training programs to show your skills as a clinical research monitor.

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.
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 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.
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 Training
Advanced Clinical Research Associate Certification (ACRAC)
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1
Introduction
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Accreditation
FREE PREVIEW -
CME Handout
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Common Terminology Used In Clinical Research - Reference Glossary
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Commonly Used Abbreviations and Terms in Clinical Research
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2
Roles and Relationships in Clinical Trials
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Duties and Responsibilities of a Clinical Research Associate (CRA, Monitor)
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Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)
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Communication between Blinded and Unblinded Staff
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Contract Research Organizations (Delegation, Responsibilities, Management )
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3
Sponsor and Investigator Roles
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ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles
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ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators
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ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities
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4
Clinical Trial Design
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Advanced Designs of Clinical Trials
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Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)
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Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)
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Blinding and Unblinding in Clinical Trials
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5
ICH GCP - Overview
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An Introduction to Clinical Research
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An Overview of ICH GCP
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6
ICH GCP - Ethical Research in Vulnerable Populations
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Ethics of Research Involving Children
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Ethics of Research Involving Mentally Incapacitated
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Ethics of Research Involving Prisoners
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Ethics of Research Involving Pregnant Women and Fetuses
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7
Adverse Events
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Advanced Review of Adverse Events
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8
Clinical Trial Protocol
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The Clinical Trial Protocol - Advanced Mastery Review
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Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)
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Protocol Deviations and Violations
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Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)
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10
IRB and DSMB
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Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)
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Data Safety Monitoring board- DSMB
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11
Review Questions
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REVIEW: 71 Review Questions for ICH GCP (optional, for study use)
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12
Site Monitoring Visits
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Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)
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13
Site Qualification Visit (SQV)
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Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)
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Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)
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14
Site Initiation Visit (SIV)
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Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"
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15
Routine Monitoring Visit (RMV)
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Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)
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16
Site Close-Out Visit (SCOV)
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Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)
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17
Tools for Monitoring Visits
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Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)
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Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)
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18
Audit and Inspections
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Audits and Inspections in Clinical Trials
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FDA Bioresearch Monitoring Program (BIMO)
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FDA Warning Letter
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Audits and Inspection Review Questions (optional for study purposes, not graded)
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19
Review Questions
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REVIEW A: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)
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20
SDV and Informed Consent
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ICH GCP Section 4.8 Informed Consent
FREE PREVIEW -
Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)
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Minimizing Source Data Queries In Clinical Trials
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Case Report Form
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Guidelines for Designing and Completing Case Report Forms
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Do’s and Don’ts of a Case Report Form Design
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22
Quality Control and Safety
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Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)
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ICH GCP - Safety of Human Subjects in Clinical Research
FREE PREVIEW
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23
Technology in Trials (IVRS, CTMS, EDC)
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ICH GCP - Trial Management, Data Handling, and Record Keeping
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Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)
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Clinical Trial Management System-CTMS
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Electronic Data Capture and Remote Data Capture Basics
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Electronic Regulatory Submission and Review
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Modernized Monitoring (Remote, Risk-based, Centralized)
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An Overview of Remote Monitoring - COVID-19 Update
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Remote Monitoring of Clinical Trials and EMRs
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Centralized Monitoring
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25
Pharmacovigilance and Regulatory Affairs
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Advanced Practice of Pharmacovigilance
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Regulatory Affairs for Clinical Trials
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Investigational Product
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Investigational Product Storage and Dispensing
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Investigational Product Accountability in Clinical Trials
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27
Local and Central Labs
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Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)
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28
Review Questions
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REVIEW PART B: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)
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29
Regulatory Documents
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Regulatory Documents in Clinical Trials
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Delegation of Authority Log – DOAL
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Investigators Brochure (IB)
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CFR 21 Part 11 - Electronic Signatures
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Code of Federal Regulations
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CFR 21 Part 11
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31
New Drug Application
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The Investigational New Drug (IND) & New Drug Application (NDA) Process
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Investigator Initiated Multi-Center Trials
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IND and IDE AE Reporting
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Safety Reporting Requirements for Sponsor Investigators of An IND
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32
Trial Master File
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Essential Regulatory Documents Binder Tab Organization (Trial Master File)
FREE PREVIEW -
Trial Master File Reference Guide
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Regulatory Training Quiz
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Disclosures and Payments for PI, Site, Patients
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Financial Disclosure- Duties and Strategies for Clinical Studies
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Payments and Budgeting for Investigators and Site
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Advertisement Aid in Subject Recruitment and Retention
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Patient Recruitment, Retention, and Compliance
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Patient Recruitment in Clinical Trials
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Patient Engagement and Retention in Clinical Trials
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Patient Adherence and Compliance in Clinical Trials
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35
Misconduct and Fraud
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Scientific Misconduct and Fraud
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Detecting Falsification
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36
Review Questions
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REVIEW PART C: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)
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37
Site Visit Templates
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SQV Checklist
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SQV Questionnaire
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SQV Assessment
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SQV Follow Up Letter
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SIV Agenda
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SIV Confirmation Letter
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SIV Report
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RMV Confirmation Letter/Fax
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RMV Report
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RMV Follow Up Letter
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CRA TRANSITION Letter/Email/Fax
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SCOV Confirmation Letter
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SCOV Agenda
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SCOV Report
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SCOV Follow Up Letter
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REFERENCE Module
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38
Interviewing and Career
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Interview Preparation
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Interview Preparation
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39
Final Examination
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Competency Exam
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CCRPS Reviews
Clinical Research Associate
Accelerated
Zehra Abbas
Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with histo...
Read MoreAccelerated 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.
Read LessACRAC
Mary Dahodu
Great course with high knowledge impaction. Platform also was easy to navigate.
Great course with high knowledge impaction. Platform also was easy to navigate.
Read LessDedication 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.
The diligence and direction provided by this course material has inspired my inner confidence to climb high to reach the pinnacle of my ambitions.
Read LessRefreshed 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.
Best refresher for clinical researchers. A lot of content but can skim modules if you know them well.
Read Lessa 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 ...
Read MoreIf 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.
Read LessCCRPS 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...
Read MoreI 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.
Read LessPhd 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 ...
Read MoreVery 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
Read Lesstwo 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.
CRA training took me about 2 weeks straight. I learned a lot and videos were very refreshing. It was noticed by recruiters on resume.
Read LessDetailed 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...
Read MoreThis 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.
Read LessA 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...
Read MoreI 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.
Read LessLearn 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.
Exceptional information not found anywhere else. Everything has an example. Content just makes sense as dry as reviewing protocols and guidelines can be.
Read LessLifechanging 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...
Read MoreThe 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
Read LessClinical research associate certification
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.
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.
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.
Advanced clinical research associate certification through a highly regarded training program like CCRPS gives you the skills and knowledge to have an edge over other job seekers who are not yet advanced certified.
Clinical Research Associate Salary
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 $79,799 in 2020.
What does a clinical research associate do
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.
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.
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
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.