Job Posting: This Program Manager position is responsible for managing the regulatory affairs operations of the Clinical Research Office (CRO) within Cedars-Sinai Medical Center's Samuel Oschin Comprehensive Cancer Institute (SOCCI). Position requires extensive knowledge in the federal, state, and local regulations and guidance governing clinical trial conduct. Incumbent will guide, direct, and provide oversight of the regulatory affairs staff in the pursuit of efficient, compliant regulatory management. This position will lead the development and dissemination of role-specific orientation for the regulatory staff, facilitate continuing education opportunities and promote professional development of staff. Responsible for monitoring timeliness, quality, and compliance, while recognizing opportunities for improvement. Works with others in a cooperative manner, exercising diplomacy, respectfulness, tactfulness, and professionalism at all times. Primary Duties and Responsibilities:
Direct and manage regulatory staff within the SOCCI CRO. Meet with staff on a regular basis to assess program performance (timeliness, quality, etc), workload assessment, training opportunities, and professional growth interests. Develops communication and compliance reporting tools which are demonstrated via weekly status reports to investigators, CRO leadership and SOCCI leadership accordingly.
Communicates with program physicians regularly to communicate timelines, status updates, and receive feedback on emerging trends/issues.
Actively participates in the strategic planning process of the Clinical Research Office. Makes recommendations in conjunction with Health System Manager and CRO Director to consider revisions to existing policies and procedures or the need to new policies and procedures.
Work collaboratively with the SOCCI Quality Monitoring Core to support preparations for external audits and to respond to audit reports by developing corrective action plans and subsequently implementing and documenting progress of plans.
Work collaboratively with the SOCCI CRO Training and Education Core to successfully develop, deliver and monitor role-specific training for regulatory staff. Development and facilitation of continuing education opportunities in addition to education and/or re-training of staff following audits, or changes in federal, state, or local guidelines (FDA, IRB, GLP, GCP, ICH guidelines, etc.).
Responsible for recruiting, hiring, and management of regulatory staff including performance reviews.
Represents the SOCCI CRO on Medical Center/Health System committees and task forces as assigned. Serves as a Liaison to promote Clinical Research at the state and federal levels.
Works effectively and cooperatively with others in achieving organizational goals; maintains harmonious working relationships.
Qualification Requirements/Preferences: Education Certifications/Licensure Experience Physical Abilities Educational Requirements: Bachelor's Degree, Healthcare, Management, Business or related field preferred Experience: 5 year Management, Program Management, or related 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.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly comp...etitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.