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Regulatory Associate, Clinical Research Management Office (CRMO) - Lombardi Comprehensive Cancer Center (LCCC)
This position is responsible for participating in all regulatory related activities for 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, sponsor-initiated, and NCI NCTN clinical research studies. Duties include but are not limited to:
Responsible for coordinating and facilitating IRB submissions including but not ! limited to initial submissions, amendments, consent modifications, reportable new information or deviations, and continuing reviews (as needed) while assuring regulatory compliance.
Responsible for maintaining regulatory updates in OnCore (Clinical Trial Management System) and tracking regulatory work and progress for the department.
Responsible to provide dear and regular regulatory update communications with investigators and research staff (study team) throughout the various stages of the study lite cycle, including informing personnel about new regulatory policies, procedures, consent or risk modifications, and protocol amendments.
Responsible for the creation and revisions to informed consent document and HIPAA authorization forms.
Responsible for maintaining trial master regulatory files and essential documents including financial disclosure forms, FDA Form 1572s, delegation logs, and other study-related documentation.
Prepares for and participates In sponsor/CRO monitoring visits and audits and FDA Inspections as needed.
Provides additional regulatory support as needed to investigators and study team I directing and coordinating investigator-initiated research such as clinicaltrlals.gov registration and submission/maintenance of annual approval for Investigational New Drug (IND) applications to the FDA as needed.
Internal Quality Assurance Work and other duties as assigned by manager.
Bachelor's Degree in a related field with a minimum of 3-5 years' experience in regulatory affairs or clinical research required; Consideration given to combination of education and experience
SoCRA, ACRP, RAPS, or CIP certification preferred
Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
Outstanding organizational skills, oral and written communication skills
Exceptional attention to detail
Knowledge of institutional, state and federal regulatory guidelines
Ability to learn quickly and work independently and efficiently with minimal supervision
Ability to independently prioritize tasks, and to work under pressure
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Internal Number: JR06082
About Georgetown University
Established in 1789, Georgetown is the nation's oldest Catholic and Jesuit University. Georgetown is one of the world's leading academic and research institutions, offering a unique educational experience that prepares the next generation of global citizens to lead and make a difference in the world.