Regulatory Associate I, Lombardi Comprehensive Cancer Center - Georgetown University Medical Center
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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). The incumbent will 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, 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.
Perform all duties in accordance with applicable laws and regulations. Adhere to Georgetown University Medical Center's philosophies, policies, and SOPs. Work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP.
This position reports to and works closely with the CRMO Regulatory Manager and requires excellent communication skills and the ability to interact effectively with a wide variety of individuals.
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
Bachelor's Degree in a science related field required.
One to three (1-3) years regulatory affairs or clinical research experience required.
SoCRA, ACRP, RAPS, or CIP certification preferred.
Strong candidates exhibit:
Strong working knowledge of FDA, NCI, OHRP, and Good Clinical Practice.
Excellent verbal and written communication skills.
Excellent organizational skills and attention to detail.
Reliable and able to prioritize competing responsibilities.
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