Regulatory Coordinator - Sarcoma Clinical Trials
Overview
The Regulatory Coordinator leads regulatory efforts for sarcoma clinical trials under PI direction and manager oversight. Responsibilities include coordinating protocol submissions preparing regulatory documents and maintaining records to ensure compliance with DFCI DF/HCC policies federal regulations and ICH/GCP guidelines. Collaboration occurs across faculty study teams external institutions pharma representatives and federal agencies. Work is fully remote from New England states. Mission focuses on advancing cancer research while fostering inclusive environments.
What You'll Do11
- 1Prepare and submit all protocol applications amendments and continuing reviews to FDA OBA and other agencies
- 2Submit regulatory documentation including IND/IDE applications FDA annual reports and Serious Adverse Event reports
- 3Maintain regulatory files for each study ensuring sponsor and industry requirements are met
- 4Track study recruitment enrollment and progress using regulatory databases
- 5Coordinate monitoring and auditing visits with investigators sponsors and auditors
- 6Establish and track post-startup submission processes for SRC/IRB approvals
- 7Communicate with stakeholders during start-up providing updates and ensuring completion of all activities
- 8Create and maintain tracking for deviations violations exceptions and other events
- 9Facilitate communication between study teams sponsors and regulators regarding status training and amendments
- 10Present regulatory status at research meetings and maintain knowledge of current regulations
- 11Assist Clinical Research Manager with regulatory training and implementation of new guidelines
Requirements8
- 1Bachelor’s degree or one year experience as Dana-Farber Associate Regulatory Coordinator
- 20-1 year experience in medical scientific research or technology oriented business environment preferred
- 3Basic understanding of clinical trial conduct
- 4Excellent written and oral communication skills
- 5Ability to maintain confidentiality and demonstrate strong decision making
- 6Proficiency with computers Microsoft applications and databases
- 7Experience with medical terminology
- 8Minimum of five years experience in regulatory roles within Dana-Farber Cancer Institute
Salary Insight
$56 - $62k per year
Location
Required Skills
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