Regulatory Coordinator - Center for Cancer Therapeutic Innovation jobs in United States
Dana-Farber Cancer Institute
- $56K/yr - $62K/yr
- 0–1 years exp
Responsibilities
- 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; Industry sponsor, DF/HCC sponsored etc
- 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 with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third-party auditors
- 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, provide regular updates and ensure all start-up activities are completed
- Create and maintain 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. Ensure various regulatory reporting required are met, Study Sponsor, FDA, IRB etc
- Establishing and maintaining 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
- 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; responsible for the systematic documentation / tracking when applicable
- 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
Preferred
- 0-1 years of experience in a medical, scientific research, or technology-oriented business environment
- a basic understanding of clinical trial conduct
Benefits
- Remote work with occasional time on campus
- Glassdoor
- 3.9
- Cancer treatment and research institute for children and adults.
- Boston, Massachusetts, USA
- http://www.dana-farber.org
- Late Stage
- Total Funding
- $138.08M
- Key Investors
- Yawkey Foundation
- Elaine and Eduardo Saverin Foundation
- The DeGregorio Family Foundation
- 2026-06-09
- Grant· $50M
- 2025-11-24
- Grant· $20M
- 2025-05-06
- Grant· $1M
- Leadership Team
- Benjamin Ebert
- President and CEO
- Prafulla Gokhale
- Director, Lurie Family Imaging Center
- Recent News
- Boston Globe
- Dana-Farber, Beth Israel begin construction of new $1.68 billion cancer hospital
- 2026-10-19
- PR Newswire
- Alpheus Medical Opens Enrollment in New Clinical Trial for Butterfly Glioblastoma
Qualifications
- 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 proficient in the use of computers, Microsoft applications and databases
- Requires experience with medical terminology
- a bachelor's degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator
- 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
- A basic understanding of clinical trial conduct
- a bachelor’s degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator
Required skills
- Clinical Research Regulatory Compliance, Clinical Trial Conduct, FDA Regulatory Reporting, IRB Submissions, Medical Terminology, Microsoft Applications
Preferred skills
- a basic understanding of clinical trial conduct
Experience
