Regulatory Operations Manager - Pediatrics

The Clinical and Translational Investigation Program (CTIP) was established in 2010 to centralize and standardize conduct of clinical research within the Dana‑Farber/Boston Children’s Cancer and Blood Disorders Center. The mission of CTIP is to provide comprehensive infrastructure to collaborating investigators to conduct clinical and translational research relevant to children with cancer and blood disorders. The CTIP Regulatory unit provides pan‑CTIP support as part of our clinical research infrastructure.

It supports interventional studies to the IRB as well as assists with FDA submissions and IND management. Reporting to the CTIP Associate Director for the Regulatory unit, the Regulatory Operations Manager (ROM) oversees the CTIP Regulatory Unit, manages the development and quality control of protocol documents prior to IRIS submission, assists with New Protocol Application (NPA) vetting and prioritization, and ensures that IRIS submission, review and approval timelines and institutional benchmarks are met.

ROM also helps develop necessary processes and workflows, works collaboratively with other clinical research colleagues to share best practices and training / professional development initiatives for regulatory coordinators.

The ROM (along with Regulatory Coordinators) is responsible for closely managing regulatory submissions and the communication process, 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.

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, educate tomorrow’s physicians / researchers, and work with amazing partners, including other Harvard Medical School‑affiliated hospitals.

• Meet regularly with leadership / key stakeholders to identify, prepare, and ensure quality and regulatory compliance and completeness of all submissions into IRIS prior to submission.
• Assist in the oversight of the program’s clinical trial portfolio and all related regulatory and compliance metrics requirements. Maintain knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
• Ensure oversight of the day‑to‑day coordination and overall management of sponsor activities for assigned clinical trials; industry sponsored, multi‑center, PI‑initiated trials, grant development and management, and secondary use protocols in collaboration with key stakeholders.
• Meet regularly with program manager(s) to review and collaborate regarding regulatory workload prioritization. Work with leadership to identify priority trials and complete submissions through IRIS. Process protocols through DFCI Institutional Review Board (and other institutions’ IRBs).
• 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.
• Support the disease team’s IND/IDE applications to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA).
• Support the maintenance of the essential document…