Clinical Trial Project Management, Monitoring, Site Initiation, Protocol Design

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 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.

Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions

  • 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 Experienced Clinical Research Professionals to meet the following career pathways. Typical Clinical Research Project Management Job Titles the candidates can apply after this training program are:

PROJECT MANAGEMENT – CLINICAL RESEARCH JOB TITLES
  • Clinical Program Manager
  • Manager of Office Sponsored Programs
  • Clinical Data Project Manager
  • Research Business Operations Analyst
  • Clinical Research Manager
  • Clinical Trial Project Manager
  • Manager, Integrated Clinical Trials
  • Clinical Study Manager

A Clinical Research Project / Study Manager (CRM) is responsible for the monitoring, data collection and analysis, and reporting of clinical trials performed and follow Ethical practices, ICH, GCP and Clinical Safety guidelines per U.S. and international markets.
The CRPM training emphasizes on practical aspects as presentations in the reference to the role performed by CRM into the industry.
Our program is approachable which provides in-depth knowledge and practical exposure to roles and responsibilities performed by Clinical Research Project Manager / Study Manager. It gives insight into topics.

CLINICAL RESEARCH PROJECT MANAGEMENT AND TRIAL MONITORING
CLINICAL RESEARCH ASSOCIATE 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

ADVANCED CLINCIAL RESEARCH ASSOCIATE TOPICS

1)  Clinical Trial Budget

2)  Investigator Selection

3)  Pre-Study Visit

4)  Protocol

5)  Informed Consent Preparation

6)  Investigational New Drug (IND) Application

7)  Institutional Review Board (IRB) Regulatory Correspondence

8)  Case Report Form (CRF)

9)  Site Monitoring

10)  Co-Monitoring Visits

11)  Study Initiation Visit

12)  Clinical Trial Management Systems (CTMS) Tracking Recording

13)  Trial Master File

14)  Database Lock

15)  Audit

ADDITIONAL ADVANCED CLINICAL RESEARCH TOPICS

1) Risk Based Monitoring (RBM)

2) FDA Audit process for Clinical Research

3) Clinical Trial Project Management (CTPM) and Time-lines

4) Development of Monitoring Plan

5) Protocol Deviation/Violation Management

6) Trial Master File and QC Management

7) Clinical Data Reconciliation and Archiving

8) Management and Reconciliation of Investigational Product

9) Advanced Clinical Research Management Modules 1 thru 4

10) Planning and Conducting Global Clinical Trials

11) Management of a Successful Clinical Research Site – Part A & B


The EXCERCISES Covered in the CRPM training program are:

1.  Clinical Trial Budget

2.  Investigator Selection

3.  Pre-study site visit

4.  Protocol

5.  Informed Consent Form

6.  IND Application

7.  IRB Regulatory Correspondence

8.  Clinical Trial Budget

9.  Investigator Selection

10.  Pre-study site visit

11.  Protocol

12.  CTMS Track Recording

13.  Trial Master File

14.  Database Lock

15.  Audit

  • I am very thankful to Q tech learning center team for providing training in Clinical Research Project Management (CRPM), as it will be helpful for me to gain experience in real-time.

    Paul A

  • The training helped me enhance my skills. The training was given in a very well planned, organized and professional manner.

    Neepa Y

  • The program was extremely helpful and the instructions were very knowledgeable. Thank you very much.

    Lily W

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