Course Structure

Week 1: Foundations of Clinical Project Management

Class 1: Ethical and Regulatory Foundations in Clinical Research

• Understanding ethical principles in clinical trials (e.g., Belmont Report).
• Development and review of informed consent forms.
• Overview of human subject protections, privacy regulations, and compliance.
• Managing potential conflicts of interest in clinical research.

Class 2: Regulatory Requirements and Trial Frameworks

• Key global regulatory frameworks (FDA, EMA, ICH-GCP).
• Overview of investigational product/device accountability and compliance.
• Introduction to the IND and EU Clinical Trial Authorization (CTA) processes.
• Pre- and post-approval reporting requirements.

Week 2: Clinical Trial Design and Operations

Class 1: Study Design and Protocol Development

• Understanding clinical trial designs, endpoints, and hypothesis generation.
• Protocol development and review for investigator-initiated trials.
• Study feasibility assessments and project timelines.

Class 2: Operationalizing Clinical Trials

• Development of study management tools (e.g., risk assessment and monitoring plans).
• Role of statistical elements in trial design and operational decision-making.
• Integrating risk-based quality management principles into trial operations.

Week 3: Study Management and Team Coordination

Class 1: Resource and Budget Management

• Development and negotiation of clinical trial budgets.
• Managing cross-disciplinary teams and resource allocation.
• Financial oversight: billing compliance (standard of care vs. protocol-specific).

Class 2: Vendor and Stakeholder Management

• Oversight of vendors: labs, CROs, IRB/IEC, and recruitment technology providers.
• Strategies for vendor selection and performance monitoring.
• Effective communication with stakeholders to ensure trial success.

Week 4: Monitoring, Documentation, and Compliance

Class 1: Study Monitoring and Documentation

• Preparing for site initiation visits and monitoring plans.
• Best practices for source document verification and case report form reviews.
• Managing protocol deviations, noncompliance, and corrective and preventive actions (CAPAs).

Class 2: Study Close-Out and Reporting

• Conducting trial close-out activities: site audits, document retrieval, and study decommissioning.
• Finalizing regulatory submissions and study summaries.
• Ensuring proper archival of essential documents (e.g., TMF).

Week 5: Audits, Leadership Development, and Career Preparation

Class 1: Preparing for Audits and Inspections

• Principles of GCP inspections and audits: purpose, scope, and outcomes.
• Preparing for sponsor and regulatory audits.
• Post-inspection actions: addressing findings and implementing corrective actions.

Class 2: Leadership Skills and Career Development

• Applying leadership, management, and mentorship principles in a clinical project setting.
• Resume building and interview preparation tailored for Clinical Project Manager roles.
• Simulated interviews with expert feedback to build confidence and competence.

Program Highlights

• Hands-On Learning: Practical exercises, real-world case studies, and mock sessions.
• Certification Prep: Aligned with ACRP-PM certification content areas to prepare for exams.
• Career Advancement: Focused sessions on leadership and stakeholder management.

Tangible Benefits:

• ✔ Career Readiness in 5 Weeks
• ✔ Resume and Interview Prep
• ✔ On-the-Job Support

Career Benefits:

• 🌍 Remote Work Opportunities
• 💰 Salary Potential: $160,000 - $198,000