Regulatory Affairs Specialist

The Regulatory Affairs Specialist (RAS) positions provide advanced expertise and regulatory support to 600+ investigators and research staff members at DFCI, focusing on standards and techniques for performing job functions typical in the development and/or conduct of FDA regulated research from an operational and regulatory compliance perspective. These positions currently support 25 research groups within DFCI and work with the investigators and study teams at various time points during a research protocol lifecycle. This includes but is not limited to external audit coordination and responses, assistance in determining which regulations apply to their research, consultation and education regarding regulatory requirements, review of FDA submissions for investigator-held IND or IDE research, and review of select protocol and monitoring processes prior to IRB review. The Regulatory Affairs Specialist (RAS) positions are critical to successfully achieving ongoing clinical research expansion and regulatory compliance at DFCI.

The selected candidate may only work remotely within the New England states (ME, VT, NH, MA, CT, RI).

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world-renowned clinicians, innovative researchers, and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS, and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

REGULATORY STRATEGY

• Keeps abreast of relevant regulatory procedures and changes in the federal and local regulatory climate.
• Responsible for facilitating, overseeing, and managing regulatory inquiries regarding protocol development, human subject protections, Good Clinical Practice (GCP) guidelines, and DFCI and DF/HCC policies.
• Serves as a centralized regulatory resource for Sponsor-Investigators and their study teams to ensure internal and external processes are established and functioning.
• Provides regulatory input pertinent to the creation, internal review and validation, and submission of investigator-sponsored regulatory filings to the FDA (primarily Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications). Activities include but are not limited to advice and oversight regarding IND/IDE determination; guidance and assistance with preparation of IND/IDE applications; coordination and oversight of IND/IDE submissions; and compliance with local, federal, and international requirements for periodic amendments and supplements.
• Monitors, utilizes, and maintains CTO tracking and control systems to manage regulatory-associated processes, including but not limited to e-Regulatory Management and the IND and IDE databases.

CLINICAL TRIAL OPERATIONS

• Problem-solves with or advises investigators and study teams on regulatory aspects that could impact the planning and development of research protocols and other protocol documents in order to ensure timely scientific/IRB review and approval.
• Evaluates research protocols for administrative completeness, compliance with DF/HCC administrative policies and procedures and applicable regulatory requirements, and operational components specific to domestic and international multicenter trials in order to facilitate timely review and approval of trials and the safe, effective, and efficient conduct of trials at DFCI.
• Assesses the acceptability of regulatory documentation to comply with regulatory requirements for clinical trials.
• Contributes to the development, review, and maintenance of standard operating procedures and working instructions related to the conduct of clinical trials at DFCI.
• May be assigned to oversee various operational aspects of the EPIC and OnCore applications used by the DFCI research enterprise, including but not limited to activation procedures, report development and generation, and identification of system enhancements.

INTERFACING

• Provides information on regulatory requirements to assigned disease program partners.
• Interacts with other clinical trials offices, departments, and regulatory inspection teams, as required.
• Contributes to the CTO regulatory and clinical research educational and training curriculum by assisting with the delivery of training for general research personnel or being responsible for training of regulatory staff on current and new regulatory requirements.
• Provides guidance to investigators and study teams regarding completion of IRB regulatory submissions (e.g., new project applications, activation, amendments, and continuing reviews) and recommendations on how best to address specific issues and concerns identified through the scientific review and IRB review processes.

LEADERSHIP & PROFESSIONALISM

• Participates in the development and implementation of DFCI regulatory initiatives.
• Contributes to the development and functioning of the Regulatory Affairs program by identifying issues changes and developing innovative ways to view and resolve the issue.
• Participates in professional associations and serves on institutional and department/division committees and task forces.

• Bachelor’s Degree in life sciences or other health-related discipline required, with a minimum of 5 years of related experience, or 3-5 years of related experience with a Master’s Degree.

COMPETENCIES:

• Must be able to perform day-to-day responsibilities independently with little or no co-worker support or supervision.
• Has intermediate knowledge of and is very proficient in scientific concepts and research design; participant safety considerations and local clinical research policy; medicines development and regulation; device development and regulation; GCP; communication (2-way to complex messages); and the delivery of training on such topics.
• Can easily identify problems or potential obstacles and resolve many independently without escalation, and is very proficient in the ability to assist others in the resolution of complex issues.

KNOWLEDGE, SKILLS & ABILITIES REQUIRED:

• Must possess excellent attention to detail and follow through, organizational, communication, and interpersonal skills. Position requires the capacity to comprehend complex structures and connections.
• Must have the ability to exercise good judgment in ambiguous situations and have a proven history of adaptability within a rapidly changing environment.
• Requires the ability and initiative to prioritize and handle a variety of tasks and assignments simultaneously.
• Strong analytic and problem-solving skills and the ability to effectively manage a large workload independently with minimal supervision are required.
• Computer skills include the use of Microsoft Office applications and databases. Working knowledge of Livelink, EPIC, and OnCore applications is desirable. Familiarity with medical terminology is required.

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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