Regulatory Associate I

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

The Regulatory Associate 1 position is responsible for conducting regulatory activities for clinical trials in the Lombardi Clinical Trials Office (CTO) of Lombardi Comprehensive Cancer Center (LCCC). The incumbent will prepare, maintain, and coordinate regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for multi-institutional, industry-initiated, and National Cancer Institute NCTN clinical research studies.

• Create, coordinate, and facilitate regulatory submissions of oncology clinical research trials, which include, but are not limited to, initial review committee submission, protocol amendments, consent form revisions, routine progress reports and continuing review applications, serious adverse events, protocol deviations, and audit results.

• Create and revise informed consent documents, HIPAA forms, and other regulatory documentation. Submit applicable documents to study sponsors as required.

• Organize study regulatory files including regulatory submissions, essential regulatory documents, and trial communication.

• Enter new trial information, trial updates, regulatory submission data, and upload approved documents to the Clinical Trials Management System (CTMS) ensuring accuracy of data.

• Participate in study activation management activities, ensuring forms and requests are completed accurately and in a timely manner.

• Effectively and efficiently communicate trial status and updates to investigators, CRMO team members, outside departments and committees, trial sponsors, and other pertinent personnel throughout the trial lifecycle.

• Assist with compiling regulatory‑related metrics for use by senior management.

• Attend assigned Disease Group meetings and provide updates on trial activity.

• Attend protocol‑related training and complete all required study training in the required timeframe.

• Prepare for and participate in trial site initiation visits, monitoring visits, close‑out visits, and audits.

• Submit applications to the Food and Drug Administration for Investigational New Drug (IND) applications as required.

• Maintain research practices using Good Clinical Practice (GCP) guidelines.

• Other duties as assigned.

All Lombardi CTO Regulatory Associates perform all duties in accordance with applicable laws and regulations, while adhering to Georgetown University Medical Center’s philosophies, policies, and SOPs and work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP.

This position reports to and works closely with the Lombardi CTO Regulatory Team Manager and requires excellent communication skills and the ability to interact effectively with a wide variety of individuals.

• Regulatory Team Manager

• Disease Group members:
  Principal Investigators, Physicians, Clinicians

• Lombardi CTO Team Members:
  Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians

• External department faculty and staff:
  Institutional Review Board (IRB), Scientific Review Committee (SRC), Radiation Safety Committee, Office of Research Quality Assurance (ORQA), Clinical Research Operations Office (CROO), Research Pharmacy

• Clinical trial sponsors, auditors, and study monitors

• Bachelor’s Degree in a science related field required.

• Three to five (3-5) years regulatory affairs or clinical research experience required.

• SoCRA, ACRP, RAPS, or CIP certification preferred

• Strong working knowledge of FDA, NCI, OHRP, and Good…