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Cancer Research Breakthroughs Start with People like You
As the Clinical Research Manager, Clinical Operations for the Cancer Clinical Trials Office at the Samuel Oschin Comprehensive Cancer Institute (SOCCI) you will be responsible for the planning, organizing, managing, and controlling the daily operations of Clinical Operations Unit and ensures development is consistent with NCI Comprehensive Cancer Center designation. Assures all program development related to clinical trials within the Cancer Clinical Trials Office follows the guidelines mandated by Federal and local requirements including FDA research regulations and the International Conference on Harmonisation (ICH) Good Clinical Practices (GCPs) and the Cedars Sinai Institutional Review Board.
As the Clinical Research Manager, Clinical Operations you will also be responsible for:
Manage the Clinical Operations Unit team comprised of seven (7) highly skilled and efficient clinical research program managers in an effort to assure compliance with regulatory agencies and increase procedures and efficiencies with the ultimate goal of increasing enrollment on clinical trials at SOCCI.
Programmatic Development: Work in conjunction with Principal Investigators and CCTO Leadership to accomplish goals, projects and research initiatives for assigned services/disease teams
Manage the performance, development, and evaluation of the Clinical Operations Unit team. Utilizes metrics to manage operations and staff performance
Clinical Trial Reporting: Generates protocol status reports for key stakeholders including Principal Investigators, CCTO leadership, clinical teams, institutional review board etc. Accountable for accuracy of trial information in all trial databases and tracking systems
Special Projects: Participates or coordinates on both interdepartmental and intra-departmental organization-wide research projects as requested. Provides leadership, organizational, creative, or clerical support to established and new research initiatives
Responsible for implementing a program to mentor new clinical research staff as well as providing ongoing education through focused in-services and recurrent meetings for cancer institute staff: research nurses, study coordinators, and data managers.
Performs regular audits on departmental research projects, databases and research protocols to ensure data quality is complete and accurate.
Collaborates with the Quality Management Core to ensure comprehensive quality assurance (QA) and quality control (QC) program throughout the cancer institute.
Serves as the SOCCI resource for sponsor, cooperative group, and federal audits and is available to investigators and the research staff for routine and for-cause audit preparation and assistance.
Initiates changes that demonstrate increased efficiency, cost effectiveness, streamlined communication, and improved satisfaction and service to our internal and external customers.
Collaborates with Associate Director of Research Operations, to facilitate financial recovery
Evaluates IT solutions to increase operational efficiency and financial recovery.
Assist in the development of standard operating procedures (SOPs) to ensure that the Clinical Operations Unit adheres to institutional standards and federal regulations.
Maintains knowledge of hospital, state, federal guidelines on the use of human tissue
Directs the development of policies, procedures, and quality standards
Minimum Essential Skills:
Advanced knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols
Clinical research experience; SOCRA/ACRP certification
Experience in interviewing/hiring process and performance management
Possess strong decision-making skills and the ability to problem solve and troubleshoot issues
Strong organizational skills with the ability to manage large volumes of information
High level of accuracy and attention to detail
High level of comfort with technology
Strong computer skills; Ability to gather data and document procedures
Ability to plan work and coordinate multiple projects
Ability to contribute to preparation and delivery of reports, trainings and SOPs
Customer oriented and ability to work within, build and lead a team
Seven (7) years minimum of clinical research operations, development and management preferably in an academic medical center, highly desired
Five (5) years or greater of experience managing a team of clinical research staff, required
Five (5) years or greater of experience working as a clinical research nurse, highly desired
Bachelor's Degree, required
Master's Degree, preferred
Bachelor's or Master's Degree in Nursing, highly desired
RN License, preferred
Working Title: Manager, Clinical Research Operations - Cancer Clinical Trials Office
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 t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive 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.