Regulatory Coordinator Job at Dana-Farber Cancer Institute (Boston)

Regulatory Coordinator

Dana-Farber Cancer Institute

Location:
United States , Boston

Category:
Quality Control

Contract Type:
Not provided

Salary:

55530.00 - 61700.00 USD / Year

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Job Description:

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 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 Trials Offices at the various DF/HCC institutions.

Job Responsibility:

Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval
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.
Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement
Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion
Assists in the preparation and coordination of assigned study monitoring and auditing visits
Track and manage assigned new protocol start-up packet
initiate, facilitate, and monitor study start-up progress to ensure established benchmarks are met
Communicate and collaborate with clinical trial key stakeholders through the start-up process
Create and maintain tracking for all subsequent submissions to the SRC/IRB
Establishing and maintaining regular communication with study team, study sponsor, applicable regulatory agencies / offices
Serve as facilitator for study team and sponsor regarding study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training
Maintain working knowledge of current regulations, regulatory guidance and or local policies
Assists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy
Present regulatory status for disease group portfolio at applicable research meetings

Requirements:

Must possess excellent written and oral communication skills
maintain confidentiality of information
demonstrate good decision-making and judgment
have attention to detail and follow-through skills
Demonstrated organization and time management/prioritization skills with the ability to work independently
Must be proficient in the use of computers, Microsoft applications and databases
Requires experience with medical terminology
The position requires a bachelor’s degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator
0-1 years of experience in a medical, scientific research, or technology-oriented business environment is preferred
a basic understanding of clinical trial conduct

Nice to have:

0-1 years of experience in a medical, scientific research, or technology-oriented business environment
a basic understanding of clinical trial conduct

Additional Information:

Job Posted:
March 22, 2026

Employment Type:

Fulltime

Work Type:

Remote work

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