Clinical Research Training Program
Fundamentals • Regulations • Trial Process • TMF • Career Pathways
Practical Clinical Research training for career-ready skills
A structured program covering the clinical trial lifecycle, international regulatory guidelines, ethics & informed consent, trial documentation and hands-on TMF and CTMS practice — designed for fresh graduates and professionals moving into clinical research.
Program Curriculum
Introduction to Clinical Research
- Fundamentals of Clinical Research
- History and Evolution of Clinical Trials
- Key Terminologies in Clinical Research
- Phases of Clinical Trials (Phase I–IV)
- Roles and Responsibilities of Clinical Research Professionals
Regulatory Environment
- International Guidelines: ICH-GCP, USFDA, EMA, CDSCO
- Ethics Committees and Institutional Review Boards (IRB/IEC)
- Informed Consent Process and Documentation
- Regulatory Submissions and Approvals
Clinical Trial Process
- Protocol Development and Design
- Investigator & Site Selection
- Clinical Trial Agreements and Budgeting
- Essential Documents (Investigator’s Brochure, Protocol, ICF, CRF)
- Trial Master File (TMF) Management
Career Pathways & Practical Training
- Job Roles in Clinical Research (CRA, CRC, CTA, QA, RA, PV Associate)
- Resume & Interview Preparation for Clinical Research Jobs
- Hands-on Exposure with Clinical Trial Documents
- Case Studies & Real-Time Scenarios
Program Benefits
Industry-Aligned Curriculum
Course content mapped to real-world clinical workflows and sponsor requirements.
Hands-On Document Training
Practical exposure to ICFs, CRFs, TMF and regulatory submission documents.
Placement Support
Resume & interview support, mock interactions, and hiring partner introductions.
Tools & Software Covered
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture (EDC) Tools (overview)
What You Will Learn
- Clinical trial lifecycle and key roles within a study team.
- Regulatory requirements, ethics and informed consent best practices.
- Protocol development, site selection and essential trial documents.
- How to structure and maintain a Trial Master File (TMF) and eTMF.
- Practical skills for CRA, CTA and CRC roles including documentation and monitoring basics.
Assessments & Capstone
- Module-wise quizzes and practical document exercises.
- Written exams and applied knowledge assessments.
- Capstone: TMF assembly & monitoring mock study case with feedback.
Career Pathways & Job Roles
Roles you can target after this program:
- Clinical Research Associate (CRA)
- Clinical Research Coordinator (CRC)
- Clinical Trial Assistant (CTA)
- Regulatory Affairs Specialist
- Quality Assurance (QA) Analyst
- Pharmacovigilance Associate
Employers
CROs, pharmaceutical companies, hospitals and regulatory bodies.
Career Growth
Progress from CTA/CRC → CRA → Senior CRA / QA / RA roles.
Salary Outlook
Competitive entry-level packages with growth as you gain monitoring and regulatory experience.
Frequently Asked Questions
Who can join?
Fresh graduates (Life Sciences, Pharmacy, Nursing, Biotechnology) and professionals seeking a career change into clinical research.
Will I get hands-on exposure?
Yes — TMF assembly exercises, CTMS walkthroughs and real-time case studies are included.
Is placement assistance provided?
Yes — resume building, mock interviews and employer introductions are part of the program.
Ready to start your Clinical Research career?
Enroll now for practical training, document skills and placement support.