Regulatory Associate I – Clinical Trials

About the role

The Regulatory Associate I supports the Lombardi Clinical Trials Office (CTO) at the Lombardi Comprehensive Cancer Center. This entry‑level position ensures that oncology clinical research studies comply with institutional, state, and federal regulations.

Key responsibilities

• Create, coordinate, and facilitate regulatory submissions for multi‑institutional, industry‑initiated, and NCI NCTN clinical trials.
• Prepare and revise informed consent forms, HIPAA documents, and other regulatory paperwork.
• Maintain organized regulatory files and upload approved documents to the Clinical Trials Management System (CTMS).
• Communicate trial status to investigators, sponsors, and internal teams throughout the study lifecycle.
• Assist with metrics reporting, attend disease‑group meetings, and support site initiation, monitoring, and audit activities.
• Submit IND applications to the FDA as required and adhere to Good Clinical Practice (GCP) guidelines.

Required profile

• Strong attention to detail and ability to manage multiple regulatory documents.
• Effective written and verbal communication skills.
• Ability to work collaboratively with investigators, sponsors, and cross‑functional teams.

Required skills

• Experience with Clinical Trials Management System (CTMS) for data entry and document management.
• Knowledge of Good Clinical Practice (GCP) standards.