Regulatory Coordinator - Head & Neck Oncology

The Regulatory Coordinator (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager, and/or the Clinical Trials Office to complete the regulatory requirements of the Head & Neck Oncology clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. The role works collaboratively with personnel at all levels, including faculty, study team members, DF/HCC partners, cooperative groups, clinical trials experts, pharmaceutical representatives, federal agencies, and other research organizations, and interacts with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ), and the Clinical Trials Offices at the various DF/HCC institutions. This position's work location is fully remote with occasional time on campus in Boston, MA. The selected candidate may work remotely only from a New England state (ME, VT, NH, MA, CT, RI). Responsibilities Prepare and submit all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval Prepare and submit regulatory documentation such as IND/IDE applications, FDA annual reports, and Serious Adverse Event reports to the appropriate regulatory agencies including FDA and OBA Prepare, maintain, and organize regulatory files for each assigned study in compliance with sponsor requirements Maintain regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion Assist in the preparation and coordination of assigned study monitoring and auditing visits with study coordinators, investigators, DF/HCC ODQ, industry sponsors, and third‑party auditors Track and manage new protocol start‑up packets; initiate, facilitate, and monitor study start‑up progress to ensure benchmarks are met Communicate and collaborate with key stakeholders during the start‑up process, provide regular updates, and ensure all start‑up activities are completed Create and maintain tracking for subsequent submissions to SRC/IRB, including protocol and consent amendments, safety reporting, deviations, violations, exceptions, and other events Maintain regular communication with study teams, sponsors, and regulatory agencies to relay required information and ensure systematic documentation and tracking Serve as facilitator for study teams and sponsors regarding study status, critical safety issues, upcoming protocol and consent amendments, and applicable protocol training Maintain working knowledge of current regulations, regulatory guidance, and local policies Assist the Clinical Research Manager with regulatory-based training and implementation of new or revised regulations, guidance, and local policies Present regulatory status for the disease group portfolio at applicable research meetings Knowledge, Skills, and Abilities Required Excellent written and oral communication skills, confidentiality, good decision‑making and judgment, attention to detail, and follow‑through skills Demonstrated organization and time‑management/prioritization skills with the ability to work independently Proficiency in computers, Microsoft applications, and databases Experience with medical terminology Minimum Job Qualifications The position requires a bachelor’s degree or one year of experience as a Dana‑Farber Associate Regulatory Coordinator. Additionally, 0‑1 year of experience in a medical, scientific research, or technology‑oriented business environment is preferred, along with a basic understanding of clinical trial conduct. SUPERVISORY RESPONSIBILITIES: None PATIENT CONTACT: None 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. Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications. Pay Range 55,530.00 − 61,700.00 USD #J-18808-Ljbffr Dana-Farber Cancer Institute