The Regulatory Coordinator II (RC II) will work directly for the Clinical Trials Office to complete the FDA regulatory requirements for Investigational New Drug (IND) clinical research studies. The RC coordinates aspects of FDA submissions, prepares and submits regulatory documents, and maintains records on assigned INDs to ensure regulatory compliance with DFCI and HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions when applicable.
The Institutional IND Regulatory Coordinator works directly for the Clinical Trials Office to complete and oversee FDA regulatory requirements specific to vaccine research or other critical DFCI-developed research products. This position serves as the primary reporting contact for the Institutional IND portfolio managed by the CTO Regulatory Affairs Core. The Institutional IND RC centrally prepares, submits, and maintains records on assigned INDs to ensure regulatory compliance with all Food and Drug Administration (FDA), National Institutes of Health Office of Science Policy (NIH OSP), and institutional biosafety committee (IBC) requirements. This position works collaboratively with various departments within DFCI and the other HCC institutions, as well as with representative from federal agencies. As necessary, the Institutional IND RC assists the CTO Regulatory Affairs Core with other required submissions to FDA, yearly Principal Investigator Worksheet (PIW) updates for DFCI physicians participating in National Cancer Institute (NCI) research, regulatory binder reviews for audit/inspection preparations, and other regulatory or compliance initiatives.
This position's work location is fully remote with occasional time on-campus in Brookline, MA. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third-party auditors.
Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.
Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, DF/HCC sponsored etc.
Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc.
Track and manage assigned new protocol start-up packet; initiate, facilitate, and monitor…