Senior Regulatory Coordinator

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).

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.

• Regulatory Compliance
• 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.
• Clinical Trial Management
• 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.
• Key Stakeholder Interfacing
• 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
• Leadership and Professionalism
• 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
  

Supervisory Responsibilities

May have direct supervisory responsibilities, from 1-5 direct reports

• 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.

Required Competencies

• Must be able to perform all duties without supervision. Has expert knowledge of and fully proficient in the following areas: DFCI, DF/HCC, ICH/GCP, FDA policy / guidance / regulation; an understanding of the IRB submission & approval process; Regulatory Binder maintenance; PI Initiated / Multi-Center Trials; protocol and consent design and development and FDA IND and other regulatory required submissions. Can demonstrate and articulate the above to staff and can act as a coach or mentor for regulatory staff.

Knowledge, Skills, And Abilities Required

• Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills.
• Demonstrated organization and time management/prioritization skills with the ability to work independently are required.
• Must be proficient in the use of computers, Microsoft applications and databases.
• Requires experience with medical terminology.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

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