Join Cedars Sinai as a global leader in research and technology, moving toward the forefront of medical advancements with our scientists making medical and scientific breakthroughs that save lives.
As the Clinical Research Manager - Clinical Operations
for the CCTO of the Samuel Oschin Comprehensive Cancer Institute (SOCCI) you will be responsible for the planning, organizing, managing, and controlling the daily operations of assigned areas of the CCTO and SOCCI and ensures development is consistent with NCI Comprehensive Cancer Center designation. Assures all program development related to clinical trials within the CCTO follows the guidelines mandated by Federal and local requirement s 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:
Programmatic Development: Work in conjunction with Principal Investigators and CCTO Leadership to accomplish goals, projects and research initiatives for assigned services/disease teams
Manages 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
Builds and manages a team of highly skilled and efficient clinical research staff including program managers, clinical research coordinators, clinical research associates, and research nurses 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.
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
· Seven (7) years minimum of clinical research operations, development and management
· Five (5) years of greater of experience managing a team of clinical research staff
· BA/BS required
· MA/MS preferred
· ACRP/SoCRA (or equivalent) certification preferred
Email Nancy Gonzalez
for more information.