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Manager, Clinical Research Operations - Cancer Clinical Trials Office

Company: Cedars Sinai
Location: Los Angeles
Posted on: May 5, 2021

Job Description:

Share Requisition # 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.Cancer Research Breakthroughs Start with People like YouAs 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 standardsMinimum 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 teamExperience:Seven (7) years minimum of clinical research operations, development and management preferably in an academic medical center, highly desiredFive (5) years or greater of experience managing a team of clinical research staff, requiredFive (5) years or greater of experience working as a clinical research nurse, highly desiredEducational Requirements:Bachelor's Degree, requiredMaster's Degree, preferredBachelor's or Master's Degree in Nursing, highly desiredLicense/Certification Requirements:ACRP/SoCRA certificationRN License, preferred* Working Title: Manager, Clinical Research Operations - Cancer Clinical Trials Office* Department: SOCCI Clinical Research Office* Business Entity: Academic/Research* City: Los Angeles* Job Category: Academic/Research* Job Specialty: Academic/Research Services* Position Type: Full-time* Shift Length: 8 hour shift* Shift Type: DayCedars-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 (see below) 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.

Keywords: Cedars Sinai, Los Angeles , Manager, Clinical Research Operations - Cancer Clinical Trials Office, Executive , Los Angeles, California

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