Regulatory Affairs Coordinator

Responsibilities

• Maintain regulatory binders and essential documents for active oncology trials after study activation
• Prepare and submit IRB continuing reviews, amendments, safety reports, and protocol deviations
• Manage sponsor and FDA correspondence, including IND safety reports and annual reports
• Track regulatory timelines for assigned studies and ensure compliance with FDA, ICH/GCP, and institutional requirements
• Maintain site staff training records, delegation logs, and financial disclosure forms
• Prepare for regulatory audits and sponsor monitoring visits
• Keep assigned studies up to date in the eRegulatory system (Veeva, Florence, or similar)
• Communicate with sponsors, CROs, and IRBs on submissions and approvals
• Assist with protocol amendments, consent form updates, and site-level regulatory correspondence

Qualifications

• 2 years of clinical research regulatory experience
• Oncology or hematology trial experience; industry-sponsored Phase 1–3 preferred
• Working knowledge of FDA regulations, ICH/GCP, and IRB submission processes
• Experience with post-activation regulatory work, including continuing reviews, amendments, safety reporting, and deviations
• Experience with eRegulatory systems such as Veeva Vault or Florence eBinders
• Familiarity with CTMS platforms such as OnCore, Medidata, or REDCap
• Strong organizational skills and the ability to manage 5–15 active studies
• CCRP or CCRC certification preferred, not required