The Tisch Cancer Institute

All investigators and key research personnel (e.g., faculty, nurses, coordinators, and data managers) must hold research credentials prior to engaging in cancer-related research. The research roadmap outlines institutional training requirements. This includes the following:

• Signed and dated CV
• Valid medical or professional license (if applicable)
• Valid Human Subjects Protection Training certificate required every three years
• Clinical Research Billing Compliance Training
• Financial Conflicts of Interest Training
• Rigor, Reproducibility, and Ethical Behavior in Research Training (required every three years)
• Good Clinical Practice Training (recommended every three years)
• Health Insurance Portability and Accountability Act Training (required annually)

CRSU in collaboration with the TCI’s Cancer Research Training and Education Coordination (CRTEC) conducts a yearly five-part eight-hour investigator training workshop series for clinical investigators. This program consists of interactive modules, case studies, and real-world examples. Participants develop the skills and knowledge to excel as principal investigators while upholding the highest standards of ethical conduct and research integrity. From understanding the fundamental principles of good clinical practice to navigating the intricate responsibilities of a principal investigator, participants gain real-world insights into ensuring patient safety, data integrity, and regulatory compliance. Workshops explore issues such as operational intricacies, ethical challenges, and best practices in clinical trial conduct. By the end of the program, participants will be equipped to ensure patient safety, maintain data integrity, uphold ethical standards, and effectively lead clinical trials from initiation to closure.

The Clinical Research Support Unit conducts a 25-hour immersive clinical research orientation program that covers a variety of topics including informed consent, HIPAA in research, finance and budgeting, study start-up process, research oversight committees, eligibility confirmation, adverse events, prompt reporting of unanticipated problems, data and safety monitoring activities, regulatory affairs, good documentation practices, and research systems. Participation is mandatory for all newly hired clinical research professionals and optional for existing staff (as remediation or supplemental training).

Prior to patient enrollment, clinical research professionals must complete self-directed training modules that cover human subject protection, Good Clinical Practice, HIPAA and data security, data and safety monitoring, standard operating procedures, electronic systems and software, and cultural sensitivity and implicit bias in patient care. In the training, participants learn to perform key aspects of their research support roles and gain an understanding of The Tisch Cancer Institute’s research operations.

The Clinical Research Support Unit aims to foster a supportive and efficient work environment and facilitate professional growth and retention. Continuing education is provided in a curated monthly lecture series on topics ranging from clinical trial operations to advanced study results. A virtual training library provides clinical research professionals with instant access to lecture materials and recordings. Quarterly wellness days for all staff and a peer-led Committee for Collaboration and Connection are designed to create a culture of engagement, social connection, and mentorship within the work environment.