Clinical Research Associate | CRA Training
Course:  Clinical Research Associate
Code:  CRAT
Delivery:
Virtual – Job Focused Self-Paced Online.
(Along Exercise Solutions – Role based tasks)
Post Training Assistance (PTA):
Includes resume support, narrative and mock.
Duration:  8 Weeks / 200 Hours
Online Access :
Qtech-Learning Management System (Q-LMS)
Fees : $1,094.39 USD
Now Only $656.40     BUY NOW
Application : APPLY NOW
Save on tuition and gain scholarship

Course Description:

Qtech-Sol is a Clinical Science Training Provider. This course provides Foundation learning to work as CRA or CRC. This is a job and title focused program. The course emphasizes about role of CRA towards protocol design, site initiating, conducting, trial monitoring and managing clinical trials data capture and audits. The course curriculum is designed to give an edge to obtain job as CRA with Pharmaceuticals, Biotech, Medical Device, Clinical Research Organizations (CROs) and with Research Clinics.

A Clinical Research Associate (CRA) manages clinical trials and studies related to pharmaceutical and biotechnological products, drugs and procedures. They are in charge of recruiting study participants, collecting patient data, creating study documentation and conducting quality assurance audits to ensure study protocols are in order. Clinical Research Associates also compile and finalize reports from long-term clinical trials.

The CRA acts as a liaison between the study’s sponsor CRO (pharmaceutical company) and the clinics (Site) where the study takes place. Because results of a clinical trial must be kept entirely transparent and not influenced by the interests of the sponsor, this is a critical role. A successful CRA will be detail oriented, highly educated, and able to communicate clearly with both sponsor and clinical representatives.

The Clinical Research Associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. Students get exposed to real-time practices and case studies towards clinical protocol development, Case Report forms (CRFs), Trial Master File (TMF), Clinical Trial Management System (CTMS), Clinical Trial Budgeting, Trial Audit process and Monitoring. Insight of GCP-ICH, FDA-EMA SOPs, and Guidelines for conducting Clinical Trials.

  • 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, Toxicology or Healthcare Administration.

  • 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
  • Career Pathways

    The program objective is to help Clinical Research Associate to meet the following career pathways, after completing this practicum program. Students can apply for below open job titles based on highest education background and prior experiences (if any).

CLINICAL RESEARCH JOB TITLES
  • Clinical Research Associate
  • Clinical Research Coordinator
  • Regulatory Coordinator
  • Research Associate
  • Clinical Trials Admin Assistant
  • CTMS 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