Cedars-Sinai Manager, Clinical Research - Regulatory (Cancer Institute) in United States
The Samuel Oschin Comprehensive Cancer Institute (SOCCI) is searching for a Clinical Research Regulatory Manager to join its management team. In collaboration with the Director of the Clinical Research Office (CRO) of the Samuel Oschin Comprehensive Cancer Institute (SOCCI), the manager assures all regulatory program development within the CRO is compliant with federal, state, and local regulations and in alignment with the National Cancer Institute's (NCI) Cancer Center Support Grant guidelines. The manager builds and oversees a team of highly skilled research staff and is accountable for the delivery of efficient, compliant, and quality-driven regulatory services to the investigators at SOCCI.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
•Works with the CRO Director and SOCCI Executive Director to develop, manage, and grow a robust, comprehensive regulatory unit supporting investigators in the development, activation, conduct, and reporting of cancer-relevant clinical trials.
•Provides content expertise and training for faculty and staff in areas of regulatory affairs, sponsor-investigator support services, and requirements related to the NCI’s Protocol Review and Monitoring System. Ensures that all federal, state, and local regulations, Good Clinical Practices, ICH, ClinicalTrials.gov, and Institutional Review Board requirements are met.
•Maintains a centralized office composed of knowledgeable, professional staff supporting clinical research services related to:
o Protocol Review & Monitoring System
o Data and Safety Monitoring Committee
o Regulatory Affairs
o Protocol Development Core (investigator-initiated trials and multi-center support)
•Responsible for strategic planning, organizing and oversight of the regulatory research operations. Participates in the preparation of annual reports, presentations, and NCI data reproting requirements. Prepares activity reports for SOCCI leadership to inform business decision. Analyzes, identifies, and recommends strategic organizational improvements. Works collaboratively with institutional leaders, peers, and external parties to develop and implement solutions to improve efficiencies and increase compliance.
•Provides supervision, guidance, and mentorship to unit leaders and staff. Fosters professional growth development of staff and accountable for staff performance and compliance.
•Interacts with SOCCI program leaders, Disease Research Group leaders, and SOCCI faculty to foster the development of investigator-initiated clinical trials and improve efficiencies in clinical research management.
•Represents Cedars-Sinai and/or SOCCI at local, state, and national meetings.
Bachelor's Degree is required
ACRP/SoCRA (or equivalent) certification preferred.
8 years minimum directly related experience (clinical research regulatory and staff management experience)
Physical Demands: (e.g., lifting, standing, walking)
Stand dynamically to perform a function and move to perform another.
Stand statically in one place to perform a function without changing location.
Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.
Perform continuous operation of a personal computer for four hours or more.
Use hands and fingers to handle and manipulate objects and/or operate equipment.
Climb stairs and/or ladders.
Bend, crouch, stoop, stretch, or crawl.
Bend upper torso and reach up and out with hands and arms.
Balance the body while walking, standing, crouching, or stooping to prevent falling.
Perform unaided lifting of objects, please list the amount of weight that would be lifted, along with the frequency required.