Brookline, Massachusetts

The Associate Director for Research Operations will report directly to the Clinical Trails Office Senior Director.?? This position will be responsible for management and oversight of the CTO???s Central Regulatory overall operations and for the direct supervision of the Regulatory Operation Managers, and indirect ongoing oversight of regulatory coordinators and consent writers. The Associate Director for Regulatory Operations will ensure compliance with all regulatory policies and guidelines including federal, state, local, as well as the policies and procedures outlined by DFCI and the Dana-Farber Harvard Cancer Center (DF/HCC) consortium. This position will be responsible for ensuring the DFCI CTO Metrics Program is executed; oversight and monitoring of determined key performance indicators (KPI), workload tool, quality control of all documents submitted into regulatory submission portals (IRIS, FDA portals).?? Responsible for the conduct of high-quality regulatory compliance through training, education, strategic planning, and the use of metrics analyses. Under the direction of the DFCI CTO Senior Director, this position will provide regulatory operational support, strategic guidance, oversight, and training to the Regulatory Operations Managers. ??Will collaborate with the CTO Associate Director of Regulatory Affairs with specific regard to external regulatory audits; FDA / EMA / Industry Sponsor for guidance and strategic navigation.?? The Associate Director for Clinical Trials will work collaboratively with disease program Directors, Clinical Research Directors and Research Managers, the Clinical Trials Office Co-Directors, and the Clinical Trials Office Senior Management Team to promote excellence in clinical research.?? 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. Central Regulatory Operations Metrics Program Responsible for assisting with the development, execution and ongoing oversight of regulatory submissions including New Protocol Applications and amendments, submission timelines, to closely monitor the IRB review, approval, and activation process. Supervise / Oversee Regulatory Operations Managers to closely track regulatory activities, identify barriers / obstacles preventing meeting outlined Key Performance Indicators and for implementing mitigating steps to meet Protocol Submission, Approval and Activation (PSAA) Initiative goals. Responsible for reporting on PSAA Initiative goal progress monthly to key stakeholders in DFCI research leadership; CTO Senior Director, Office of Clinical Research and to Research Administration. Develop and report quarterly goal status reports to share with stakeholders, regulatory staff, and disease center leaders. Monitor results of regular quality control of regulatory submissions. Maintain dashboard of regulatory operations submission metrics for monthly reporting to DFCI research leadership. Central Regulatory Operations Overall Management Meet weekly with Regulatory Operations Managers to review weekly activities, to discuss wins / successes and or issues that need attention / escalation to ensure timeline goals are met. Review workload distribution within and across regulatory PODs. Work with key stakeholders to identify, collaborate and resolve issues interfering with abilities to meet initiative goals. Meet with lead Industry Partners to enhance collaborative relationships to support common goal outcomes. Other duties as assigned Central Regulatory Operations Strategic / Technical Oversight Oversee regulatory submissions management systems (IRIS, FDA portals) eRegulatory platform point person eConsent platform point person Develop and deploy regulatory metric dashboard. Central Regulatory Operations Staff Hiring, Supervision, Training and Development Hire, Train and provide supervision to all Regulatory Operation Managers Assist Regulatory Operations Managers with their POD hiring, training and supervision of their regulatory staff when needed. Report quarterly analysis on significant trends in hiring, training, and supervision; including action plans to address. 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. Bachelor's degree in a field relevant to research compliance and 7 years of progressively responsible experience with conducting and managing clinical trials. A Master's degree or higher with 5 years of progressively responsible experience managing clinical trials and experience with metrics tracking and analysis is highly desirable.?? Experience in an academic institution is highly preferred, especially working in collaborative efforts with upper administrators, faculty, and research staff as well as research support personnel.?? Must have expertise in research ethics and the responsible conduct of research. 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 groups as protected by law.

Brookline, Massachusetts

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