Clinical Research Associate / Coordinator (CRAT)

Clinical Research Project Management and Trial Monitoring (CRPM)

This program is currently being reviewed by the Private Training Institutions Branch (PTIB) of the Ministry of Advanced Education, Skills & Training for approval.

3 Students Enrolled

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 a protocol development, assessment and reporting of adverse events and explains GCP-ICH guidelines along with other necessary regulatory information. The course emphasizes on 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 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 opportunity in 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.

Category: Clinical Research Lessons: 26 Lessons Duration: 08 Weeks / 200 Hours Language: English
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 education background, certifications, and prior experiences (if applicable), to evaluate your eligibility. Qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources qpdc@qtech-solutions.ca 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

  1. Upgrading the Knowledge required.
  2. Better Resume Placement for promising jobs.
  3. Low Investment, high learnings
  4. Learn from Anywhere, Anytime at your pace.
  5. Job and Title Based Tasks as followed and Practiced in industry
  6. Applying Concept into Real-time (Policies, governance and tools)
  7. Work on Role Based Tasks followed and Practiced in industry
  8. Mocks and Narratives for Client Discussions
  9. Readiness to work with limited support
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

 

  • Curriculum Overview

    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 role performed by CRM into 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 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

Instructor

qtech-admin

5.00 average based on 3 ratings

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Reviews

  • 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.

    Maureen D (Texas)

    Paul A


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

    Gamal

    Neepa Y


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

    Sangeetha

    Lily W