Regulatory Associate - Clinical Research Management Office - Georgetown University Medical Center

Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

Requirements

Regulatory Associate - Clinical Research Management Office - Georgetown University Medical Center

Georgetown’s Clinical Research Management Office (CRMO) provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. This includes all regulatory documents, IRB submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on the Lombardi website, and design of electronic case report forms for institutional trials.

Job Overview

The Regulatory Associate is responsible for conducting regulatory activities for clinical trials in the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC). They prepare, maintain, and coordinate regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for investigator-initiated, industry-initiated, and National Cancer Institute NCTN clinical research studies.  Duties include but are not limited to:

• Create, coordinate, and facilitate regulatory submissions of oncology clinical research trials, including but 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
• Perform all duties in accordance with applicable laws and regulations
• Adhere to Georgetown University Medical Center’s philosophies, policies, and SOPs
• Perform duties in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP

Work Interactions

Reporting to and working closely with the CRMO Regulatory Manager, the Regulatory Associate interacts effectively with a wide variety of individuals, including but not limited to:

• Regulatory Manager
• Disease Group members: Principal Investigators, Physicians, Clinicians
• Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, Laboratory Technicians
• External department faculty and staff: Institutional Review Board (IRB), Clinical Research Committee (CRC), Radiation Safety Committee, Office of Research Quality Assurance (ORQA), Clinical Research Operations Office (CROO), Research Pharmacy
• Clinical trial sponsors, auditors, and study monitors

This position has been designated as Hybrid. Please note that work mode designations are regularly re