Regulatory Coordinator - Breast Oncology

Overview

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the Breast 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. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Tri...