Regulatory Associate, Clinical Research Management Office (2 opportunities) - Georgetown University
Regulatory Associate, Clinical Research Management Office (2 opportunities) - Georgetown University Medical Center
Georgetown University Clinical Research Management Office (CRMO), a shared institutional resource of the Lombardi Comprehensive Cancer Center (LCCC), provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. This includes all regulatory documents, Institutional Review Board 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.
The Regulatory Associate participates in all regulatory related CRMO activities, preparing, maintaining, and coordinating regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for investigator initiated, sponsor-initiated, and National Cancer Institute (NCI) National Clinical Trials Network (NCTN) clinical research studies. Reporting to the Regulatory Manager in streamlining processes and assisting in the implementation of standardized functions, the Regulatory Associate has duties that include but are not limited to:
For All Trials
- Coordinates and facilitates Clinical Research Coordinator and Institute Review Board (IRB) submissions, including initial submissions, amendments, Informed Consent Form (ICF) changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance.
- Enters study information and ensuring 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 makes revisions to informed consent and HIPAA forms.
Regulatory Management - Industry Sponsored Trials
- Maintains essential regulatory documents including Financial Disclosure Form (FDF), Statement of Investigator (Form FDA 1572), Delegation of Authority (DOA) logs, and other study-related documentation.
- Prepares for and participates in sponsor monitoring visits and audits.
- Regulatory Management - National Clinical Trials Network (NCTN) Trials
- Communicates with NCI Central Institutional Review Board (CIRB) Initiative as applicable.
Regulatory Management - Investigator Initiated Trials
- Maintains essential regulatory documents.
- Assists investigator with clinicaltrials.gov registration and updates.
- 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 (SOP).
- Attends applicable LCCC meetings - for example, disease group meetings, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits.
- Bachelor's degree in a related field
- 3 - 5 years of experience in regulatory affairs or clinical research
- Preference for SoCRA, ACRP, RAPS, or CIP certification
- Strong working knowledge of FDA, NCI, OHRP and/or ICH GCP
- 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
- Excellent communication skills and the ability to interact effectively with a wide variety of individuals including investigators, clinical research coordinators, administrative staff, and representatives from cooperative groups, clinical research organizations, other institutions, and pharmaceutical companies.
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