Remote Regulatory Coordinator for Cancer Trials

Dana-Farber Cancer Institute; Boston (MA); On-site; USD 56,000 - 62,000; Full time

Job summary

Dana-Farber Cancer Institute seeks a Regulatory Coordinator to ensure regulatory compliance for CCTI clinical research. The role involves preparing protocol submissions, regulatory documents, and maintaining study records in collaboration with DF/HCC teams and external partners.

Responsibilities include IRB/SRC submissions, regulatory tracking, and coordinating start-up activities, with focus on timely communication and documentation across sponsors and agencies.

Qualifications

• 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.

Responsibilities

• Prepare and submit protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
• Prepare and submit regulatory documentation such as IND/IDE applications and FDA annual reports.
• Maintain regulatory files for each study in compliance with sponsor requirements.
• Maintain regulatory tracking databases related to recruitment, enrollment, and study progress.
• Assist in coordinating study monitoring and auditing visits with stakeholders and sponsors.
• Track and manage start-up packets and monitor start-up progress to meet benchmarks.
• Communicate with study teams, sponsors, and regulatory agencies to ensure timely information flow.
• Create and maintain tracking for all SRC/IRB submissions and regulatory reporting.

Skills

Communication

Confidentiality

Decision-making

Time management

MS Office

Medical terminology

Education

Bachelor's degree

Job description

Dana-Farber Cancer Institute seeks a Regulatory Coordinator to ensure regulatory compliance for CCTI clinical research. The role involves preparing protocol submissions, regulatory documents, and maintaining study records in collaboration with DF/HCC teams and external partners.

Responsibilities include IRB/SRC submissions, regulatory tracking, and coordinating start-up activities, with focus on timely communication and documentation across sponsors and agencies.