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