Clinical Research Associate Certification

Advanced Clinical Research Associate Certification (ACRAC)

Industry-Recognized I 250 Hours I On-Demand I 17.5 CME I 100+ Modules I GCP E6R2 Complaint I Triple-Accredited I Instant Enrollment I 2+ Week Certification
Clinical Research Associate Certification

Dream of becoming a CRA or getting promoted within the industry?

While there is an industry-wide shortage of CRAs, companies have been reluctant to fill those positions – citing insufficient training as one reason. To get your foot in the door, you need comprehensive training from a leading organization that provides you with all the knowledge and skills you need. Unfortunately, many training courses are not comprehensive enough to actually apply these tools and regulations. Thus, even experienced CRAs prefer to use us to "refresh" their training.

Start your CRA training instantly with our 2-4 month payment plans

Whether you are looking to transition from another field to become a Clinical Research Associate / Clinical Research Monitor, looking to move up within the industry, or begin a completely new career in this field, the CCRPS is the best industry choice for CRA training. This is a career that can bring in salaries of over $100,000 after three years of experience; the comprehensive ACRAC course is an educational program that opens this lucrative career path for you. Worried about financing your education? The CCRPS offers multiple payment options to suit every budget – pay in a single installment or choose a monthly payment plan.

ACRAC is the leading training program for CRAs

  • Take the fast track

    Take the fast track to a lucrative career as a Clinical Research Associate (CRA) to start earning salaries of $100,000 – 33% of new CRAs get promoted within a year

  • Get advanced training

    Get the most advanced training - ACRAC is recognized as a gold standard by many CROs in the industry thanks to its comprehensive training

  • Work at your own pace

    Work at your own pace from wherever you are with flexible online training. The 100+ modules included can be completed in as little as 2 weeks

  • Requirements

    Designed for those holding a minimum of a BA in Science, ACRAC is internationally accredited to ACCRE, ACCME, ACPE, ANCC, and Transcelerate Biopharma. In other words, upon completion of the course and the final exam, you will have a level of knowledge equivalent to (and beyond!) that of a senior CRA.

  • Syllabus

    ACRAC features 100+ modules, or 250 hours, of on-demand online training (worth 17.5 CME credits). The course has been put together by senior CRAs, enabling students to build a deep knowledge of the industry.

  • Certification

    This course can be completed in as little as two weeks, with certification and a letter of recommendation awarded after completing a 52-question exam. ACRAC also provides you with tools to help you find a job, including resume and interview guides, giving you a further edge over other applicants for the same position. ast

Worried about financing your education?

CCRPS offers multiple payment options to suit every budget – pay in a single installment or choose a monthly payment plan with no interest or credit check.

Clinical Research Associate Training

Advanced Clinical Research Associate Certification (ACRAC)

  • 1

    Introduction

    • Accreditation Statement

    • 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

Frequently Asked Questions

If you have questions, we have the answers.

  • Who can I contact with questions or for help with the course?

    You can email us at SUPPORT@CCRPS.ORG! One of our experienced course representatives will get back to you within 1-2 business days.

  • How long is the course?

    The course is fully self paced and be completed in as little as 2 week or over the course of a few months.

  • Is this Certification Accredited?

    Yes! CCRPS courses are accredited by the Accreditation Council for Clinical Research & Education (ACCRE) and jointly accredited by the American Medical Association (AMA), Accreditation Council for Pharmacy Education (ACPE), American Nurses Credentialing Center (ANCC), and Interprofessional Continuing Education (IPCE) to provide CME credits for professionals.

  • What is the exam retake policy?

    Students have 2 attempts to take the exam. If both attempts fail, students are still able to retake after a more thorough review of the course material.

  • What are the responsibilities of a CRA/Who would benefit from becoming a CRA?

    A Clinical Research Associate or Coordinator directs and supervises clinical trials that are run by physicians, nurses, and other science-degree holders. Many CRA students are actually matriculated foreign doctors who opted not to take the USMLE or repeat their residency training. In fact, some of our Clinical Research Training Students come to us immediately after moving to the U.S. wondering what to do with an MBBS degree in US. Unlike what you’ve learned during your 3-8 years in university or graduate school, Clinical Research Training after your degree is rarely a repetition of any course you’ve taken before. Thus, we have 107 Clinical Research Training modules (more than any other course available) to make sure you get the position you want as a CRA. Unlike the jobs you currently can apply to on the market, a position as a CRA is actually much more difficult to obtain. While many generic courses exist on the market; we have seen that many of these students cannot find a job because of the lack of content depth. This is why our course offers a Senior Clinical Research Associate level of training with 107 intense modules. This science-based medical position is now a high-demand job which can be done privately for pharmaceutical companies such as Pfizer, or academically in medical schools. In addition, we have the largest number of clinical research courses online.

  • Why take an online CRA Certification course?

    Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care. As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree. This is why a career as a CRA should be considered with clinical research coordinator training. We train over 100 students each month in clinical research coordinator training and clinical research associate training (depending on prior background). For those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career. Because the position is unlike actually working in the lab and more of a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

  • What is the work lifestyle and salary of a CRA?

    Many CRA positions take remote applicants and may comprise of up to 75% travel with expenses covered. CRAs with the level of training that our Certification provides can expect to make between $6,500 and $12,00 a month, with an estimated promotion rate of 33%.