Senior Regulatory Coordinator

Dana-Farber Cancer Institute • Brookline, MA

100d • Remote

About The Position

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and/or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/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 DF/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. 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 Special Projects (NIH OSP), and institutional biosafety committee (IBC) requirements. This position works collaboratively with various departments within DFCI and the other DF/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 hard copy submissions to FDA, yearly Principal Investigator Worksheet (PIW) updates for DFCI physicians participating in National Cancer Institute (NCI) research, and regulatory binder reviews for audit/inspection preparations. The work location of this position is remote with occasional time on-campus in Boston, MA. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).

Requirements

• Bachelor's degree (BA, BS) required; Master's or other advanced degree highly preferred.
• 3+ years of direct regulatory experience required.
• Must have expert knowledge of FDA and ICH/GCP guidelines.
• Previous experience with clinical trials and/or research coordination and personnel management required.

Nice To Haves

• Experience with medical terminology.

Responsibilities

• Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
• 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.
• Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, DF/HCC sponsored etc.
• Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.
• Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC QACT, Industry Sponsors, and third party auditors.
• Track and manage assigned new protocol start-up packet; initiate, facilitate and monitor study start-up progress to ensure established benchmarks are met.
• Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed.
• Create and maintain tracking for all subsequent submissions to the SRC / IRB; protocol & consent amendments, all required safety reporting, all required deviation, violation, exception or other event reporting.
• Ensure various regulatory reporting required are met; Study Sponsor, FDA, IRB etc.
• Establishing and maintaining regular communication with study team, study sponsor, applicable regulatory agencies / offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when applicable.
• Serve as facilitator for study team and sponsor with regard to study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training; responsible for the systematic documentation / tracking when applicable.
• Maintain working knowledge of current regulations, regulatory guidance and or local policies.
• Assists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy.
• Present regulatory status for disease group portfolio at applicable research meetings.

Benefits

• Inclusive and diverse work environment.
• Opportunities for professional development.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree