Clinical Research Associate, CRA, Coordinator Certification Training

This program is approved by New Jersey Department of Education (DOE) and Department of Labor and Workforce Development (DOL). Funding Option is available to qualified NJ Resident students, contact us to check on requirements.

The course provides a thorough Foundation, Advanced and Project Management related concepts focusing clinical trials, drug development, Study design, Project Management, and Monitoring concepts of Clinical Sciences in reference to roles and responsibilities performed by Clinical Research Associate. The concepts include protocol development, assessment and reporting of adverse events and explain GCP-ICH guidelines along with other necessary regulatory information. The course emphasizes on the understanding of the science and the expectations of initiating, conducting, monitoring, and managing clinical trial-related work. This training will develop the technical skills and knowledge pertaining to the roles and responsibilities of CRA – In House. Students will get exposure to real-time practices pertaining to Case Report forms (CRFs), Trial Master File (TMF), Clinical Trial Protocol, Clinical Trial Budget, and Audit. The course curriculum is designed to give an edge to obtain job opportunities in the clinical research field.

Our Programs are delivered in 2 Different ways for convenience of student:


  • Self-Paced Individual Program (SIP)
    – Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions.

  • Self-Paced Blended Program (SBP)
    – Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 7 days Post Training Assistance program for Resume preperation.
  • Admission Requirements:

    Recommended: An Associate or Bachelor’s degree in Medicine, Nursing, Pharmacy, Public health Biology, Biochemistry, Biotechnology, Chemistry, Clinical Research, Biomedical Engineering, Public health, Pharmacology, or toxicology, Medical Device & Technology, Psychology, Sociology and Healthcare Administration.

  • Institutional Scholarship / Promotion:

    Institutional Scholarship / Promotion is available for selected on tuition. We review your educational background, certifications, and prior experiences (if applicable), to evaluate your eligibility. The qualified student will be provided with the promo code for scholarship on Tuition.

    Please Email your resume to Human Resources qpdc@qtech-solutions.us to check on your eligibility. We will contact you. Qtech’s objective is to provide you the right career pathway and advancement required to meet your career goals.

  • Learning Outcomes:
    The Benefit Student Gains
    • Upgrading the Knowledge required.
    • Better Resume Placement for promising jobs.
    • Low Investment, high learnings
    • Learn from Anywhere, Anytime at your pace.
    • Job and Title Based Tasks as followed and Practiced in industry
    • Applying Concept into Real-time (Policies, governance and tools)
    • Work on Role Based Tasks followed and Practiced in industry
    • Mocks and Narratives for Client Discussions
    • Readiness to work with limited support

    LISTED AS PRIVATE SCHOOL (USA)

  • Career Pathways

    Our objective is to help students to meet the following career pathways. Typical Clinical Research Associate (CRA) Job Titles the candidates can apply after this training program are:

CLINICAL RESEARCH JOB TITLES
  • Clinical Research Associate
  • Clinical Research Coordinator
  • RN Clinical Research Coordinator
  • Clinical Research Training Coordinator II
  • Research RN Coordinator
  • Regulatory Coordinator
  • Research Nurse
  • Research Associate
  • Research Registered Nurse
  • Admin Assistant
  • Clinical Research Nurse II
  • Clinical Research Administration & Operations
  • TMF Specialist
  • Documentation Specialist
Curriculum Overview

Program is designed by industry experts meeting job and title-based learnings needed for students and young professionals to get into jobs. The training provides in depth knowledge of roles and responsibilities of Clinical Research Associate/ Clinical Research Coordinator. The curriculum includes theoretical and practical aspect of the role and tasks performed on day-to-day basis, along with exposure to various exercises per industry requirements.

CLINICAL RESEARCH ASSOCIATE / COORDINATOR
LIST OF TOPICS

1. Drug Discovery and Research Process

2. Pre-Clinical Research

3. Introduction to Clinical Trials

4. Role of Clinical Research Associate

5. Phase I Clinical Trials

6. Phase II Clinical Trials

7. Phase III Clinical Trials

8. Phase IV Clinical Trials

9. Good Clinical Practice and ICH Guidelines

10.FDA Regulations

11.Institutional Review Board (IRB)

12. Overview of Clinical Protocol

13.Clinical Protocol Design and Development

14.SOP Development

15.Case Report Form (CRF) Design

16.Clinical Trial Budget

17.Conducting Multinational Clinical Trials

18.Communication- Cross-Functional Team

19.CRA / CRC – In House Responsibilities

20.Selection of Investigator

21.Vendor Selection and Management

22.Informed Consent Preparation

23.Roles and Responsibilities of the Investigator

24.Investigator Meetings and Timelines

25.Selection of Investigator Site

26.Study Initiation

27.In-House Monitoring and Reporting

28.Trial Master File (TMF)

29.Introduction- AE Reporting

30.Preparation for Internal Audit

31 Role of CRA Monitoring

32.Subject Recruitment Process and Informed Consent

33.CRF Design and Development Monitoring Perspective

34.Source Documentation, Retention and Compliance

35. Drug Accountability Plan

36.Site Visits

37.Site Monitoring

38.Investigator-Monitor Meetings

39.Understanding Monitoring Worksheets

40.Clinical Trial and Site Audit

41. Study Close-Out

EXCERCISES

Case 1: Introduction to Clinical Trial

Case 2: FDA EMEA Regulations

Case 3: Institutional Review Board (IRB)

Case 4: Protocol Design and Development

Case 5: Clinical Trial Budget

Case 6: Case Report Form (CRF) Design

Case 7: Investigator Meeting

Case 8: Site Management and Initiation

Case 9: Informed Consent Preparation

Case 10: Trial Master File

Case 11: Adverse Event Monitoring and Reporting

Case 12: Audit

Reviews

  • Qtech Solutions Inc. has provided me with the education needed to work as a Clinical Research Associate. The program was extremely helpful and the instructions were very knowledgeable.

    Maureen D (Texas)

  • It was a very interesting CRA training course. Topic, professional presentation, Quiz and test, makes the difference between a good training session and a GREAT training session. I like the competent materials course.

    Gamal A (New Jersey)

  • The level and nature of participation was simply exceptional, concrete exercise, excellent analysis and feedback. The work assigned to interns is valuable and very useful. This CRA training is a value addition program and helps me to face the global opportunities.

    Sangeetha T (Texas)

  • Category:
    Clinical Research
  • Duration:
    08 Weeks
  • Price:
  • Language:
    English