Reporting to an Associate Director within the Clinical and Translational Investigative Program (CTIP) and the specific disease center, the Regulatory Operations Manager (ROM) is responsible for supporting disease groups research portfolio; managing the development and quality control of protocol documents prior to IRIS and/or CHeRP submission, assisting with New Protocol Application (NPA) vetting and prioritization, ensuring that IRIS and CHeRP submission, review and approval timelines / institutional benchmarks are met.??

This position is the primary point person responsible for the collaboration / navigation with the Dana-Farber Cancer Institute (DFCI) and Boston Children???s Hospital (BCH) IRB contacts, clinical trial sponsors, the designated Principal Investigator and the disease group Clinical Research Manager to facilitate and streamline each process within established timelines. ??The ROM is responsible for closely managing regulatory submissions and communication following a quality control program that ensures study documents are of the highest quality to decrease or eliminate questions/conditions that hold up the approval and activation processes.

This position mitigates inconsistencies within study documents, keeps protocols and amendments, as necessary, on track, and ensures appropriate quality control strategy at each step throughout the protocol life cycle. The ROM also works collaboratively with other ROM colleagues to share best practices, workload metric and training / professional development initiatives for regulatory coordinators. ????The ROM is a content expert regarding regulatory requirements and processes within CTIP.

• Meet regularly with the program leadership / key stakeholders to identify, prepare, and ensure quality and regulatory compliance and completeness of all submissions into IRIS and CHeRP prior to submission.
• Assist the principal investigator and Clinical Research Manager in developing the protocol budget in collaboration with DFCI/BCH Research Administration, Clinical Trials Business Offices and Grants and Contracts offices.
• Assist in the oversight of disease group's clinical trial portfolio and all related regulatory and compliance metrics requirements. Maintains knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
• Meet regularly with disease center leader, program manager (s) to review and collaborate regarding regulatory workload prioritization. Work with disease center leadership to identify priority trials and complete submissions through IRIS and CHeRP. Process protocols through DFCI and BCH Institutional Review Board (and other institutions' IRBs, as necessary).
• Identify and manage operational, logistical, and regulatory challenges related to the start-up, active, and closeout phases of the clinical trial life cycle and act as a leader in overseeing their resolution. Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and assist the disease group???s Clinical Research Manager in their resolution.
• Manage the regulatory documentation submissions that may include the preparation and submission of protocol application documents, informed consent documents, amendments, continuing reviews, events, and other submissions for SRC and IRB review and approval.
• Manage the IND/IDE applications to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA).
• Manage the maintenance of the essential document compliance for the disease group. Implementing systems to monitor and ensure regulatory document collection and maintain compliance and audit-ready state. Assist in audit preparations and represent the department during inspections, when needed.
• Assists PI and study team with protocol development, consent form development, and initial application and collaborate with the study team to develop study case report forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials.
• 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, as needed. Ensure various regulatory reporting required are met, Study Sponsor, FDA, IRB etc.
• Serve as facilitator for study team and sponsor regarding study status information, critical safety issues, upcoming protocol, consent and IDB amendments, as necessary, and applicable protocol training.
• Will be asked to provide in-service training and will serve as a resource to other research and clinical personnel regarding clinical trials, protocols, GCP guidelines, federal regulations, and site SOPs.
• Train new regulatory staff as applicable.

• Bachelor???s degree in Biology, Life Sciences, or related field required.
• 5 years of experience in clinical research and regulatory coordination required; 3 years of experience with a Master???s in related field.
• Experience in protocol development.
• Experience in an academic institution preferred.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Very proficient knowledge of and ability to execute clinical trials start-up, active and close out phases.
• Very proficient knowledge of clinical research local policy and federal regulation.
• Proficient knowledge of regulatory affairs, research ethics and the responsible conduct of research.
• Excellent organizational skills and attention to detail.
• Excellent written and verbal communication and interpersonal skills.
• Strong ability to work independently and with little direction, and balance multiple projects and tasks simultaneously.
• Strong ability to both work as a member of and effectively and proactively collaborate with multiple teams.
• Strong ability to identify and assist in managing personnel issues and to provide critical feedback to supervisees, when applicable.
• Ability to lead multiple projects simultaneously.
• Ability to prepare, with minimal supervision, a summary of a clinical trial design, objectives and activities using established guidelines and governmental regulations in a clear, concise, and health-literate format.
• Ability to easily identify complex regulatory scenarios and independently develop viable solutions to present to supervisor.

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 groups as protected by law.

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