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Clinical Research Manager, Clinical Operations - Cancer Clinical Trials OfficeRequisition # 19001425 Apply Now
Cancer Research Breakthroughs Start with Employees like You
Join Cedars Sinai as a global leader in research and technology, moving toward the forefront of medical advancements, with scientists making medical and scientific breakthroughs that save lives
Do you have a passion for healing human kind?
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:
- Ensuring all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol.
- Provide guidance to staff in establishing priorities to ensure that workflow is controlled and meets the needs of the department. Communicates and ensures compliance with institutional/departmental priorities, initiatives, safety standards, and external legal regulations.
- Build and manage 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.
- Serve as the senior on-site manager for the clinical operations established by the CCTO for which the SOCCI strategic plan.
- Direct and facilitate the process of new protocol development, review and implementation within the Department. Anticipate the effects of changing regulatory requirements. Direct the development of policies, procedures, and quality standards.
- Directs the functions and activities of staff. Responsible for interviewing, hiring and training of new clerical and management (Research) employees.
- 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.
- Develops and maintains Working Instructions, document templates, and guidelines for the conduct of cancer clinical trials and other research at the SOCCI.
- Attends local and national meetings assigned by the Institute and CCTO Associate Director and assures positive representation at these meetings.
- 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, and research pharmacy infrastructure and will participate in the prioritization and scientific review of cancer protocols at the SOCCI Protocol Review and Monitoring Committee
Seven (7) years minimum of directly related experience
ACRP/SoCRA (or equivalent) certification preferred
- Working Title: Clinical Research Manager, Clinical Operations - Cancer Clinical Trials Office
- Department: SOCCI Clinical Research Office
- Business Entity: Academic / Research
- City: Los Angeles
- Job Category: Academic / Research
- Job Specialty: Research Studies / Clinical Trials
- Position Type: Full-time
- Shift Length: 8 hour shift
- Shift Type: Day
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through March each year) as a condition of employment, and annually thereafter as a condition of continued employment.
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