Qtech-Sol Professional Development Center

Clinical Research Associate / Coordinator (CRAT)

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CRAT

Clinical Research Associate / Coordinator (CRAT)

3 Students Enrolled

 

8 Weeks / 200 Hours

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 3 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
• Self-Paced Package Program (SPP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 15 days Post Training Assistance program for Resume preperation, Interview Narratives and Mock session. Obtains Job refferal and leads for application with clients and vendors

Lessons: 41 Lessons Duration: 08 Weeks / 200 Hours Language: English
Approved By:

Clinical Research Associate / Coordinator program is Approved by New Jersey Department of Education and Department of Labor and Workforce, United States.

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.

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

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 hrs@qtech-solutions.com 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.

  • 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 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



Instructor

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5.00 average based on 3 ratings

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Reviews

  • Maureen D

    Maureen D (Texas)

    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.
  • Gamal A

    Gamal A (New Jersey)

    It was 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.
  • Sangeetha T

    Sangeetha T (Texas)

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

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