Clinical Trial Assistant (CTA) | DSA Training | Trial master file (TMF)

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.

A Clinical Research Assistant is a professional employed by a pharmaceutical, medical device manufacturing, or clinical research organization (CRO) to support administrative support, assisting with routine tests and procedures and collecting both data and samples. Responsibilities include assisting with the set-up of research equipment, performing literature searches, screening and scheduling of subjects and inputting information on to a computer system.

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. The student participates in 7 days Post Training Assistance program for Resume preparation.

  • Admission Requirements:

    Recommended: An Associate degree in Pre-Med, Nursing, Pharmacy, Public health, Biology, Biochemistry, Chemistry, Clinical Research, Psychology, Sociology and Healthcare Administration (or) High School (Health Sciences).

  • 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 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

    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


  • Career Pathways

    Upon completion of the training candidates can apply for positions.

Clinical Trial Assistant Trial Documentation Assistant
Administrative Assistant Clinical Data Assistant
Research Assistant TMF Assistant
Monitoring Visit Planner Site Communication Assistant
Curriculum Overview:

The course provides a Foundation of Clinical Sciences about roles and responsibilities performed by Clinical Trial Assistant. The topics CTA training covers includes:


1. Clinical Trial Assistant

2. Drug Discovery and Research Process

3. Pre-Clinical Research

4. Introduction to Clinical Trials

5. Phase-I Clinical Trial

6. Phase-II Clinical Trial

7. Phase-III Clinical Trial

8. Phase-IV Clinical Trial

9. FDA Regulations

10. Good Clinical Practices and ICH


11. Institutional Review Board (IRB)

12. A 6 Month Process for planning Multinational Clinical Trials

13. Communication with Cross-Functional Team

14. Overview of Protocol

15. In House CTA Responsibilities

16. Informed Consent Preparation

17. Investigator Meetings and Timelines

18. Clinical Trial Budget

19. Source Documentation Retention and Compliance

20. Investigator-Monitor Meetings

21. Trial Master File (TMF)

22. Preparing for Internal Audit


1. Introduction to Clinical Trials

2. FDA Regulations

3. Institutional Review Board (IRB)

4. Informed Consent Preparation

5. Investigator Meetings and Timelines

6. Clinical Trial Budget

7. Trial Master File (TMF)


  • 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:
    8 Weeks
  • Price:
  • Language: