The Regulatory Affairs Specialist (RAS) is responsible for providing strategic, tactical and operational direction and support to investigators and study teams for working within regulations to expedite the development and delivery of safe and effective healthcare products to DFCI patients and the world. The RAS will work closely and collaboratively with a variety of individuals at all levels throughout DFCI, including faculty, investigators and staff, and also with representatives from the pharmaceutical, biotechnology, and medical device industries, federal and international regulatory agencies, and other research organizations. The RAS will work interactively with the Dana-Farber/Harvard Cancer Center (DF/HCC) Office for Human Research Studies (OHRS) and Office of Data Quality (ODQ), as well as clinical trials offices at other DF/HCC institutions. The RAS will be supervised and supported by senior CTO management and will support the mission and goals of the DFCI clinical research program. Specific tasks and responsibilities are varied and dependent upon different types of work that are done across the various functions that comprise the regulatory life-cycle at DFCI.

This position is 4-5 days remote. Only applicants living in Massachusetts, Rhode Island, or New Hampshire at the time of employment will be considered.

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 Trials 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 and 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

• 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.

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.

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.