Regulatory Affairs Coordinator, Cancer Therapeutics

Dana-Farber Cancer Institute; Boston (MA); Vor Ort; USD 56.000 - 62.000; Vollzeit

Zusammenfassung

Dana-Farber Cancer Institute in Boston, MA seeks a Regulatory Coordinator to manage regulatory submissions, maintain study records, and ensure compliance with DF/HCC policies and federal regulations. You will collaborate with cross-functional teams, OHRS, ODQ, and external partners in a fast-paced clinical trials environment.

The role requires a bachelor’s degree or 1 year of regulatory experience, excellent communication, and strong organizational skills.

Qualifikationen

• Bachelor’s degree or 1 year of experience in regulatory coordination.
• Experience with medical terminology is preferred.
• Strong written and verbal communication abilities required.

Aufgaben

• Prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents for SRC/IRB review and approval.
• Maintains regulatory files and tracking databases for study recruitment, enrollment, and progress.
• Coordinates regulatory submissions to agencies (FDA, OBA, etc.) and supports start-up activities and audits.

Kenntnisse

Communication skills

Attention to detail

Time management

Computer skills

Ausbildung

Bachelor's degree

1 year regulatory experience

Tools

Microsoft Office

Regulatory databases

Jobbeschreibung

Dana-Farber Cancer Institute in Boston, MA seeks a Regulatory Coordinator to manage regulatory submissions, maintain study records, and ensure compliance with DF/HCC policies and federal regulations. You will collaborate with cross-functional teams, OHRS, ODQ, and external partners in a fast-paced clinical trials environment.

The role requires a bachelor’s degree or 1 year of regulatory experience, excellent communication, and strong organizational skills.