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The Regulatory Associate participates in all regulatory related activities for the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC). S/he prepares, maintains, and coordinates regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for investigator initiated, sponsor-initiated, and NCI NCTN clinical research studies. Reporting to and working closely with the regulatory manager, the Regulatory Associate has additional duties that include but are not limited to:
Coordinates and facilitates CRC and IRB submissions including, but not limited to: initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance.
Enters study information and ensures accuracy of information in Oncore.
Communicates with investigators and research staff (study team) throughout the various stages of the study life cycles.
Informs research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments.
Creates and revises informed consent and HIPAA forms, maintaining essential regulatory documents including FDFs, 1572s, DOA logs, and other study-related documentation.
Prepares for and participates in sponsor monitoring visits and audits.
Submits and maintains annual approval for Investigational New Drug (IND) applications to the Food and Drug Administration as required.
Assists in the development and implementation of policies and standard operating procedures (SOPS).
Attends applicable LCCC meetings.
Bachelors Degree in a related field
Minimum of 3-5 years experience in regulatory affairs or clinical research
Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
Outstanding organizational skills, verbal, and written communication skills with 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
SoCRA, ACRP, RAPS, or CIP certification preferred
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Internal Number: JR06408
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.