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.

What is a clinical research associate
Clinical Research Associate
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.

Clinical Research Associate
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.
Why get clinical research associate training
Clinical research associate certification
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.

Internationally-recognized clinical research certification

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.

Salary for clinical research associate
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.

  • Entry-level clinical research associate salaries can range from $47,000 - $60,000 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.
  • Salaries for experienced CRAs 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.

How to obtain a CRA job
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.

  • 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 Training

Advanced Clinical Research Associate Certification (ACRAC)

  • 1

    Introduction

    • Accreditation

      FREE PREVIEW
    • CME Handout

    • Common Terminology Used In Clinical Research - Reference Glossary

    • Commonly Used Abbreviations and Terms in Clinical Research

  • 2

    Roles and Relationships in Clinical Trials

  • 3

    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

  • 4

    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

  • 5

    ICH GCP - Overview

    • An Introduction to Clinical Research

    • An Overview of ICH GCP

  • 6

    ICH GCP - Ethical Research in Vulnerable Populations

  • 7

    Adverse Events

    • Advanced Review of Adverse Events

  • 8

    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)

  • 9

    Protocol Deviations and Violations

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

  • 10

    IRB and DSMB

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

    • Data Safety Monitoring board- DSMB

  • 11

    Review Questions

    • REVIEW: 71 Review Questions for ICH GCP (optional, for study use)

  • 12

    Site Monitoring Visits

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

  • 13

    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)

  • 14

    Site Initiation Visit (SIV)

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

  • 15

    Routine Monitoring Visit (RMV)

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

  • 16

    Site Close-Out Visit (SCOV)

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

  • 17

    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)

  • 18

    Audit and Inspections

    • Audits and Inspections in Clinical Trials

    • FDA Bioresearch Monitoring Program (BIMO)

    • FDA Warning Letter

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

  • 19

    Review Questions

    • REVIEW A: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)

  • 20

    SDV and Informed Consent

  • 21

    Case Report Form

    • Guidelines for Designing and Completing Case Report Forms

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

  • 22

    Quality Control and Safety

  • 23

    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

  • 24

    Modernized Monitoring (Remote, Risk-based, Centralized)

  • 25

    Pharmacovigilance and Regulatory Affairs

    • Advanced Practice of Pharmacovigilance

    • Regulatory Affairs for Clinical Trials

  • 26

    Investigational Product

  • 27

    Local and Central Labs

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

  • 28

    Review Questions

    • REVIEW PART B: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)

  • 29

    Regulatory Documents

    • Regulatory Documents in Clinical Trials

    • Delegation of Authority Log – DOAL

    • Investigators Brochure (IB)

  • 30

    CFR 21 Part 11 - Electronic Signatures

    • Code of Federal Regulations

    • CFR 21 Part 11

  • 31

    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

  • 32

    Trial Master File

  • 33

    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

  • 34

    Patient Recruitment, Retention, and Compliance

    • Patient Recruitment in Clinical Trials

    • Patient Engagement and Retention in Clinical Trials

    • Patient Adherence and Compliance in Clinical Trials

  • 35

    Misconduct and Fraud

    • Scientific Misconduct and Fraud

    • Detecting Falsification

  • 36

    Review Questions

    • REVIEW PART C: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)

  • 37

    Site Visit Templates

    • SQV Checklist

      FREE PREVIEW
    • SQV Questionnaire

    • SQV Assessment

    • SQV Follow Up Letter

    • SIV Agenda

    • SIV Confirmation Letter

    • SIV Report

    • RMV Confirmation Letter/Fax

    • RMV Report

    • RMV Follow Up Letter

    • CRA TRANSITION Letter/Email/Fax

    • SCOV Confirmation Letter

    • SCOV Agenda

    • SCOV Report

    • SCOV Follow Up Letter

    • REFERENCE Module

  • 38

    Interviewing and Career

    • Interview Preparation

    • Interview Preparation

  • 39

    Final Examination

    • Competency Exam