Regulatory Coordinator II - Clinical Trial Office

The Regulatory Coordinator II (RC II) will work under the direction of the Director of Clinical Research Administration for the Clinical Trials Office to complete the regulatory requirements of the clinical research projects. 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 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 Trials Offices at the various DF/HCC institutions.

This position’s work location is hybrid with two or three days per week remote/onsite at our Brookline area location. The selected candidate may only work remote days from a New England state (ME, VT, NH, MA, CT, RI).

• Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval
• Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third‑party auditors
• Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion
• Prepares, maintains and organizes regulatory files for each assigned study in compliance with study sponsor requirement;
  Industry sponsor, DF/HCC sponsored etc.
• Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc.
• Tracks and manages assigned new protocol start‑up packet; initiates, facilitates, and monitors study start‑up progress to ensure established benchmarks are met
• Communicates and collaborates with clinical trial key stakeholders through the start‑up process, providing regular updates and ensuring all start‑up activities are completed
• Creates and maintains 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. Ensures various regulatory reporting requirements are met, Study Sponsor, FDA, IRB etc.
• Establishes and maintains regular communication with study team, study sponsor, applicable regulatory agencies / offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when applicable
• Serves as facilitator for study team and sponsor regarding study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training; responsible for the systematic documentation / tracking when applicable
• Maintains working knowledge of current regulations, regulatory guidance and local policies
• Assists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and local policy
• Present regulatory status for disease group portfolio at applicable research meetings

• Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision‑making and judgment and have attention to detail and follow‑through skills
• Demonstrated organization and time management/prioritization skills with the ability to work independently are required
• Must be…