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• Serves as the on-site manager for clinical research operations in the CRO for which the TACRI strategic plan and future direction is based.
• Builds and leads all aspects of a team of highly skilled and efficient clinical research staff including clinical research coordinators, clinical research coordinators, clinical research associates, research nurses, quality personnel and others as delegated.
• Responsible for designing and implementing a program to onboard, train, and mentor new clinical research staff; works closely with the research supervisors to ensure that all staff are trained, re-assessed if needed, and re-trained if needed.
• Provides ongoing education through focused in-services and recurrent meetings for cancer institute staff including research nurses, study coordinators, clinical research associates, and regulatory staff.
• Oversees and may serve as the primary contact and resource for sponsors and cooperative groups.
• Participates in audits and coordinates the efforts of investigators and the research staff for routine and for-cause audit preparation and assistance; focus on clinical research issues during audits.
• Develops and maintains working instructions, document templates, and guidelines for the conduct of cancer clinical trials and other research at TACRI; Participates in cancer research policy revision and development.
• Coordinates meetings with departmental management to provide feedback and helps Implement operational efficiency measures.
• Completes assigned projects related to clinical research infrastructure development that will include but not be limited to cancer research radiology core services, research laboratory efficiencies, electronic medical record, clinical trial management system, and research pharmacy infrastructure.
• Works closely to develop staffing models for standardization of cancer clinical trials
• Develops and implement a comprehensive quality assurance (QA) and quality control (QC) program
• Works closely with research pharmacy and research lab to develop processes for smooth clinical operations related to research
• Works closely with PIs to constantly monitor processes related to clinical research and improve research potential.
Teamwork/Customer Relation Responsibilities
Strong interpersonal skills are needed to work effectively with patients, their physicians, and/or families; pharmaceutical company representative and other project personnel.
Must demonstrate excellent communication skills, written and verbal, and have the ability to be consistently be accurate.
Must provide consistency and continuity of quality-centered patient care for oncology patients, specifically those in consideration for or actively participating in clinical research protocols
Team Lead/Supervisory/Management Responsibilities
Strong understanding of Good Clinical Practice in Clinical Trials.
Responsible for hiring, onboarding, managing schedules, personnel actions, performance reviews, and performance improvement plans.
Supervises the day-to-day work of employees, assigns work, ensures tasks are completed and deadlines are met.
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Educational Requirements:
- Bachelor’s Degree in a related field.
- Master’s Degree in Science or related field – preferred
Licenses:
- CITI Good Clinical Practice – preferred
- Cert Clin Research Professional – SoCRA – preferred
- Six Sigma Certification – preferred
Physical Demands: Lifting, Standing, walking, sitting, carrying, pushing, pulling, climbing, stooping, balancing, kneeling, crouching, handling, grasping, hearing, talking. The physical ability and perceptive acuity to satisfactorily perform all direct and indirect patient care functions. Must be able to perform assigned duties in a demanding work environment.
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Working Title: Manager, Research Operation – The Angeles Clinic & Research Institute
Department: Angeles Research
Business Entity: Medical Network Foundation
Job Category: Academic/Research
Job Specialty: Academic/Research Services
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$80,400.00 – $132,600.00