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.
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.
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
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 Associate||Clinical Research Coordinator|
|Regulatory Coordinator||Research Associate|
|Clinical Trials Admin Assistant||CTMS Operation|
|TMF Specialist||Documentation Specialist|
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
11.Institutional Review Board (IRB)
12. Overview of Clinical Protocol
13.Clinical Protocol Design and 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
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
39.Understanding Monitoring Worksheets
40.Clinical Trial and Site Audit
41. Study Close-Out
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