Regulatory Associate – Clinical Research

About the role

The Regulatory Associate supports the Clinical Research Management Office of the Lombardi Comprehensive Cancer Center by managing regulatory activities for oncology clinical trials. This position ensures all submissions and documentation comply with institutional, state, and federal guidelines.

Key responsibilities

• Create, coordinate, and facilitate regulatory submissions for investigator‑initiated, industry‑initiated, and NCTN studies, including protocol amendments, consent forms, progress reports, and adverse event reports.
• Prepare and revise informed consent documents, HIPAA forms, and other regulatory paperwork; submit required documents to study sponsors.
• Maintain organized regulatory files and enter trial data into the Clinical Trials Management System (CTMS) with high accuracy.
• Support study activation, monitor trial status, and communicate updates to investigators, sponsors, and internal teams.
• Assist senior management with regulatory metrics and participate in disease‑group meetings.
• Prepare for and attend site initiation, monitoring, close‑out visits, and audits; submit IND applications to the FDA as needed.

Required profile

• Strong attention to detail and ability to follow GCP and institutional SOPs.
• Excellent written and verbal communication skills for interacting with investigators, sponsors, and regulatory bodies.
• Ability to manage multiple regulatory tasks simultaneously and meet tight deadlines.

Required skills

• Experience with Clinical Trials Management System (CTMS).
• Knowledge of Good Clinical Practice (GCP) guidelines.