Sr. Regulatory Specialist, Clinical Research Management Office - Georgetown Lombardi Comprehensive Cancer Center
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The Sr. Regulatory Specialist is responsible for participating in all regulatory related activities for the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC). The Sr. Regulatory Specialist 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. Assist regulatory manager with mentoring junior staff. Primary responsibilities include, but are not limited to:
Regulatory Management - These primary duties will be performed for all subcategories
Responsible for coordinating and facilitating CRC and IRB submissions including, but not limited to: initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance
Responsible for entering study information and ensuring accuracy of information in Oncore
Communicates with investigators and research staff throughout the various stages of the study life cycles
Informs research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments
Responsible for the creation and revisions to informed consent and HIPAA forms
NCTN and NCORP Trials
Communicates with NCI CIRB as applicable
Responsible for maintaining RCR updates and registration including electronic 1572s
Manage CTEP accounts and responsible for rostering
Investigator Initiated Trials
Responsible for maintaining essential regulatory documents
Assists investigator with clinicaltrials.gov registration and updates
Submit and maintains annual approval for Investigational New Drug (IND) applications to the Food and Drug Administration as required.
Industry Sponsored Trials
Responsible for maintaining essential regulatory documents including FDFs, 1572s, DOA logs, and other study-related documentation
Prepares for and participates in sponsor monitoring visits and audits.
Assists in the development and implementation of policies and standard operating procedures (SOPS)
Attends applicable LCCC meetings including, but not limited to disease group meetings, SIVs, IMVs, and COVs.
This position requires 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. The Sr. Regulatory Specialist reports to and works closely with the regulatory manager to streamline processes and assist in the implementation of standardized functions.
A minimum of 3-5 years experience in regulatory affairs or clinical research with Bachelor's degree in a related field or a minimum of 1-3 years experience in regulatory affairs or clinical research with a Master's degree.
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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