A Research Regulatory and Compliance Manager position is currently available within the Tisch Cancer Institute. The incumbent will work with Investigators and the Cancer Clinical Trials Office (CCTO) to manage National Cancer Institute-sponsored cooperative group trials for the Tisch Cancer Institute (TCI) and Icahn School of Medicine at Mount Sinai (ISMMS) Health System network. Duties include, but are not limited to: management of cooperative group clinical trials through the regulatory life cycle ensuring regulatory integrity, act as the main contact during the protocol development phase, and correspond with internal review committees and Disease Groups. The position will report to the Assistant Director of Regulatory Affairs.
The individual is responsible for the management and evaluation of National Clinical Trials Network (NCTN) and Experimental Therapeutics Clinical Trials Network (ETCTN) research programs assuring objectives are met and integrity and quality of research is maintained. Responsible for oversight of all communication with sponsor(s), IRB, DSMC, regulatory agencies, and other research related activities.
The Tisch Cancer Institute is a vital component of the Mount Sinai Health System, which is one of the largest health care systems in the nation. We are a National Cancer Institute (NCI)-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs that may one day put an end to cancer.
The primary mission of the CCTO is to assist The Tisch Cancer Institute investigators in the development, conduct, and reporting of innovative clinical research in an efficient, compliant, and scientifically sound manner. The CCTO is composed of regulatory, financial, clinical, study management, compliance, and data management personnel that support investigators and provide uniformity and consistency in clinical research. The CCTO provides management and oversight functions for coordinating, facilitating, and reporting cancer clinical trials.
Prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reporting according to institutional and departmental policies and procedures and federal regulations.
Develops and/or revises regulatory standard operating policies and procedures when needed.
Tracks new protocols through the internal start-up committee process to approval and activation, including responding to committees’ inquiries for clarification.
Gathers clinical and safety data needed to prepare and process applications for IRB annual renewal review and approval.
Collaborates with Disease Groups to prioritize the submission and activation of cooperative group clinical trials and ensuring clinical trial regulatory compliance.
Collaborates and assists with Investigators and Disease Groups in the completion of required regulatory documents including, but not limited to: Conflict of Interest forms, delegation of authority logs, legal agreements, investigational pharmacy forms, serious adverse event forms, etc.
Oversight and maintenance of Cancer Therapy Evaluation Program (CTEP) investigator registrations; including new and annual renewal registrations.
Coordinates communication with investigators and members of the research team to aid in study development and oversight throughout the life-cycle of the cooperative group clinical trial.
Assists the Disease Groups in the development of trial-specific training for the clinical staff.
Collaborates with the Financial Group on the development of the study budgets (as needed); identifies billable versus research non-billable procedures.
Manages regulatory staff supporting cooperative groups trials in TCI and the ISMMS Health System network
Mentors and trains less-experienced regulatory staff and Clinical Research Coordinators within the ISMMS Health System network
A minimum of 5 years of research experience in Regulatory Affairs or comparable regulatory experience in Oncology
Analytical skills for problem solving; attention to detail and accuracy
Solid experience in using MS Office programs and software including Word, Excel, PowerPoint, and Outlook
Internal Number: 2681018
About Icahn School of Medicine
The Icahn School of Medicine at Mount Sinai is an international leader in medical and scientific training, biomedical research, and patient care. It is the medical school for the Mount Sinai Health System, which includes eight hospital campuses, and has more than 5,000 faculty and nearly 2,000 students, residents and fellows. Our unwavering pursuit of intellectual exchange, breakthrough research, and multidisciplinary teamwork propels us ever forward in biomedical discoveries and advances. We pursue ideas that often challenge conventional wisdom to revolutionize the practice of medicine and produce dramatically better outcomes for patients. We make big, bold bets by investing in radical free thinkers and technology at the cutting edge.