What You Will Learn

• Clinical Research Fundamentals

  Introduction, CTA, CRA roles and responsibilities in clinical trials.

• Project Lifecycle Management

  CPM, CRC, PI, Steering Committees, DSMB roles and functions.

• Operational Tools & Systems

  EDC/RDC, CTMS, IWRS/IVRS, eTMF systems and applications.

• Regulatory & Ethical Compliance

  Informed Consent, eConsent, IRB/EC, SAE/AE reporting requirements.

• Strategic Planning

  Budgeting, outsourcing, risk-based monitoring, site feasibility & selection.

• Emerging Trial Models

  Decentralized trials, translation, remote oversight and digital health technologies.

Why Choose This Course?

• Content aligned with ICH-GCP and global standards for clinical trial operations.

• Learner-focused: from entering the field (CTA) to leadership roles (PI, CPM).

• Covers both traditional and decentralized trial models for comprehensive understanding.

• Practical activities and case-based learning for real-world application.

• Supplementary resources: FAQs about certification, credit recognition, career placement, and optional downloadable overview PDF.

Career Outcomes

After completion, learners can pursue roles such as:

• Clinical Research Assistant (CTA)

• Clinical Research Associate (CRA)

• Clinical Project Manager (CPM)

• Principal Investigator (PI)

• Clinical Research Coordinator (CRC)