Cedars-Sinai · 3 months ago
Clinical Research Manager, Research Operations
8700 Beverly Blvd, Los Angeles, CA, 90048, US
Full-time
Onsite
Senior Level
$55.31/hr - $96.79/hrCedars-Sinai is a leading medical center looking for a Clinical Research Manager in Research Operations. The role involves overseeing daily operations, managing budgets, ensuring compliance with laws and regulations, and providing leadership to administrative staff while supporting research initiatives within the organization.
CommunitiesHealth CareMedicalNon Profit
Responsibilities
Ensures compliance with state and federal laws, accreditation, professional and regulatory agency standards and licensure requirements. Maintain staff compliance with medical center policies, procedures and protocols
Assumes fiscal responsibility for the department including unit budget preparation, labor and supply cost management, and revenue enhancement
Responsible for tracking and reporting all high-level Capital/Operations projects. Prepares complex or highlevel regular and ad-hoc financial reports for the Department Chair and/or Institute Executive Director. Works closely with leadership to develop processes and tools to monitor research funding and activities for the area
In collaboration with the Department Chair, Institute Executive Director and/or Division Director develops business operations plans for department and for specific programs and services within it
Supervises the research protocols as mandated for research and ensures optimal levels and continuous improvement of quality within their work area. Maintains appropriate quality management and oversight programs
Supervises department employees, including responsibility for determining qualifications, hiring, maintaining and improving competence, assigning work, coaching, training (e.g. orientation, in-service and continuing education), evaluating performance, compensation, discipline and terminating employment
Interact regularly with PIs and staff to assess team needs, provide information and resolve issues
Promote a team atmosphere and manage staff regarding but not limited to the following: Manage the onboarding of new lab staff, Develop job descriptions, Conduct employee annual appraisals, Identify staffing needs, Conduct probationary period meetings with new staff, and Counsel, coach and terminate staff as appropriate
In collaboration with the Institute Executive Director and/or Division Director, develops business and operations plans for department and for specific programs and services within it
Manages the effective utilization of human resources and supplies within the department, including the development of appropriate staffing and management of productivity. Develop staffing plans in response to research and department activity. Recommend space and other resources for needed services. Participate in the selection of outside sources for needed services
Collaborates with other research, department and clinical/support service managers in other areas to help foster cross-functional process improvement, collaborative teamwork, open communication and problem solving to ensure the effective coordination and integration of services within and between units
Works closely with the Office of Research Administration and designated Research Grant Specialist to ensure all grant awards are appropriately managed and maintained for Faculty holding a primary appointment in the area
Responsible for facilitating the Faculty contracting process in coordination with Academic Human Resources
Performs all other duties as assigned
Understands CTSI program, structure, SAC governance, and its relationship to Research Institute and Cedars-Sinai Medical Center. Completed CTSI competency and Orientation Plan, Human Subject Protections (IRB) Education requirement: annual classes, CE requirements met
The Manager works with the Research Subject Advocate (RSA) Medical Director as needed for the oversight of CTRC compliance activities. The Manager is also responsible to oversee the Scientific Advisory Committee meetings to review all new protocol requests
The position also requires substantial knowledge of and experience with grantsmanship (pre- and post-award grants management), grant writing, organization and submission of continuation or competitive grant applications, supporting clinical research infrastructure
Responsible for annual reporting requirements to the NIH-NCATS, based on database compilation of clinical protocol census activity, research manuscript publications, program progress narratives, scientific highlights, investigator's, other support, young investigator awards, Core Lab voucher distribution and use, and all expenditures for patient care expenses and equipment purchases
Responsible for yearly NlH NCATS CTSI continuation budgets and 5-year competitive grant application budgets along with budget justifications and the CSRI yearly supplement budgets for the CTSI and related core programs
Responsible for oversight of various CTSI program educational activities, including the High School Mentorship, Rubenstein Resident Research Award, the Malaniak PostDoctoral Research Award, Core Curriculum training seminars for the CSRI community, and the Clinical Fellows Research Award programs
Support the on-boarding of new Research faculty recruits, ensure all systems and support is in place prior to arrival including HR, safety, immigration related matters, labs, relocation planning and execution, research space and equipment, etc
Researches variance for explanation, corrects errors and oversees the appropriate transfers in a timely manner. Oversees and assists in the preparation of the annual capital/operations budget. Works with the Research Grant Specialist to provide budget and staffing information
Maintains direct oversight of regulatory/IRB operations from start-up to closeout
Serves as sub/co-investigator on clinical trials, observational research, and biobanking protocols
Responsible for organization, preparation, and submission of investigator-initiated study applications including IND submissions to the FDA
Manages Clinical Coordinating Center (CCC) with academic and industry partners. Implements recruitment strategies and workflows to ensure top enrollment in global clinical trials
Obtains informed consent for clinical trials and research cohorts, per advanced approvals by Executive Director of Cedar-Sinai Geri and Richard Brawerman Nursing Institute
Collaborates with OLAR and EIS to assure compliance with research procedures on hospital units and documentation within the EMR
Participates in monitoring and auditing activities as well as site visits from sponsors, Clinical Research Organizations and FDA
Conceptualizes and builds research databases and case report forms (CRFs) for federally funded and industry-sponsored multi-site protocols
Develops timelines and standard operating procedure manuals for all research projects
Engages in manuscript writing, preparation, and submission. Coordinates with staff to meet the educational goals of unit
Mentors undergraduate research interns. Assists other research teams with nursing duties when asked
Provides direct patient care to research participants including performing phlebotomy and specimen collections, performing ECGSs, initiating and monitoring IV infusions, administering study drugs, performing patient assessments including vital sign measurement, and documenting accordingly, including all adverse events. Triages phone calls from research participants
Guides nursing staff in the provision of nursing care consistent with Nursing Standards of Care/Practice, the Plan for Provision of Nursing Care, The Plan for Provision of Patient Care, CSMC Code of Conduct, the Performance Improvement Plan, the Patient Education Plan and Professional Organization Standards
Qualification
Required
Responsible for the daily planning, organizing, directing and controlling of the operations of assigned area, in order to meet the needs of all customers, Faculty and support of Medical Center goals and philosophies
Assumes fiscal responsibility through preparation of unit budgets
Serves as liaison with Faculty and other personnel
Promotes the maximum growth and development of each employee
Supports research, participates in both strategic and tactical planning
Accountable to the Department Chair and/or Institute Executive Director
Maintains competency skills including the ability to interact with Faculty and staff within their assigned area, the Medical Center and throughout the Health System
Plans, organizes, manages and controls the daily operations of their area
Works closely with departmental leadership, Faculty, Principal Investigators (PIs), staff and students to provide analytical support and project management
Strategizes and collaborates with the Director and senior leadership, along with Academic Affairs regarding development and implementation of policies and procedures
Manages and supervises administrative staff; provides leadership coaching, and opportunities for professional development
Facilitates Human Resource (HR) functions for their area by collaborating with the appropriate HR partners for Faculty and department staff recruitment, visa and immigration assistance, employee relations, compensation, and benefits
Ensures compliance with state and federal laws, accreditation, professional and regulatory agency standards and licensure requirements
Maintains staff compliance with medical center policies, procedures and protocols
Assumes fiscal responsibility for the department including unit budget preparation, labor and supply cost management, and revenue enhancement
Responsible for tracking and reporting all high-level Capital/Operations projects
Prepares complex or high-level regular and ad-hoc financial reports for the Department Chair and/or Institute Executive Director
Works closely with leadership to develop processes and tools to monitor research funding and activities for the area
In collaboration with the Department Chair, Institute Executive Director and/or Division Director develops business operations plans for department and for specific programs and services within it
Supervises the research protocols as mandated for research and ensures optimal levels and continuous improvement of quality within their work area
Maintains appropriate quality management and oversight programs
Supervises department employees, including responsibility for determining qualifications, hiring, maintaining and improving competence, assigning work, coaching, training (e.g. orientation, in-service and continuing education), evaluating performance, compensation, discipline and terminating employment
Interact regularly with PIs and staff to assess team needs, provide information and resolve issues
Promote a team atmosphere and manage staff regarding but not limited to the following: Manage the onboarding of new lab staff, Develop job descriptions, Conduct employee annual appraisals, Identify staffing needs, Conduct probationary period meetings with new staff, and Counsel, coach and terminate staff as appropriate
In collaboration with the Institute Executive Director and/or Division Director, develops business and operations plans for department and for specific programs and services within it
Manages the effective utilization of human resources and supplies within the department, including the development of appropriate staffing and management of productivity
Develop staffing plans in response to research and department activity
Recommend space and other resources for needed services
Participate in the selection of outside sources for needed services
Collaborates with other research, department and clinical/support service managers in other areas to help foster cross-functional process improvement, collaborative teamwork, open communication and problem solving to ensure the effective coordination and integration of services within and between units
Works closely with the Office of Research Administration and designated Research Grant Specialist to ensure all grant awards are appropriately managed and maintained for Faculty holding a primary appointment in the area
Responsible for facilitating the Faculty contracting process in coordination with Academic Human Resources
Performs all other duties as assigned
Understands CTSI program, structure, SAC governance, and its relationship to Research Institute and Cedars-Sinai Medical Center
Completed CTSI competency and Orientation Plan, Human Subject Protections (IRB) Education requirement: annual classes, CE requirements met
The Manager works with the Research Subject Advocate (RSA) Medical Director as needed for the oversight of CTRC compliance activities
The Manager is also responsible to oversee the Scientific Advisory Committee meetings to review all new protocol requests
The position also requires substantial knowledge of and experience with grantsmanship (pre- and post-award grants management), grant writing, organization and submission of continuation or competitive grant applications, supporting clinical research infrastructure
Responsible for annual reporting requirements to the NIH-NCATS, based on database compilation of clinical protocol census activity, research manuscript publications, program progress narratives, scientific highlights, investigator's, other support, young investigator awards, Core Lab voucher distribution and use, and all expenditures for patient care expenses and equipment purchases
Responsible for yearly NlH NCATS CTSI continuation budgets and 5-year competitive grant application budgets along with budget justifications and the CSRI yearly supplement budgets for the CTSI and related core programs
Responsible for oversight of various CTSI program educational activities, including the High School Mentorship, Rubenstein Resident Research Award, the Malaniak PostDoctoral Research Award, Core Curriculum training seminars for the CSRI community, and the Clinical Fellows Research Award programs
Supports the on-boarding of new Research faculty recruits, ensure all systems and support is in place prior to arrival including HR, safety, immigration related matters, labs, relocation planning and execution, research space and equipment, etc
Researches variance for explanation, corrects errors and oversees the appropriate transfers in a timely manner
Oversees and assists in the preparation of the annual capital/operations budget
Works with the Research Grant Specialist to provide budget and staffing information
Maintains direct oversight of regulatory/IRB operations from start-up to closeout
Serves as sub/co-investigator on clinical trials, observational research, and biobanking protocols
Responsible for organization, preparation, and submission of investigator-initiated study applications including IND submissions to the FDA
Manages Clinical Coordinating Center (CCC) with academic and industry partners
Implements recruitment strategies and workflows to ensure top enrollment in global clinical trials
Obtains informed consent for clinical trials and research cohorts, per advanced approvals by Executive Director of Cedar-Sinai Geri and Richard Brawerman Nursing Institute
Collaborates with OLAR and EIS to assure compliance with research procedures on hospital units and documentation within the EMR
Participates in monitoring and auditing activities as well as site visits from sponsors, Clinical Research Organizations and FDA
Conceptualizes and builds research databases and case report forms (CRFs) for federally funded and industry-sponsored multi-site protocols
Develops timelines and standard operating procedure manuals for all research projects
Engages in manuscript writing, preparation, and submission
Coordinates with staff to meet the educational goals of unit
Mentors undergraduate research interns
Assists other research teams with nursing duties when asked
Provides direct patient care to research participants including performing phlebotomy and specimen collections, performing ECGSs, initiating and monitoring IV infusions, administering study drugs, performing patient assessments including vital sign measurement, and documenting accordingly, including all adverse events
Triages phone calls from research participants
Guides nursing staff in the provision of nursing care consistent with Nursing Standards of Care/Practice, the Plan for Provision of Nursing Care, The Plan for Provision of Patient Care, CSMC Code of Conduct, the Performance Improvement Plan, the Patient Education Plan and Professional Organization Standards
Company
Cedars-Sinai
Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service.
Founded in 1902
10001+ employees
H1B Sponsorship
Cedars-Sinai has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (91)
2023 (81)
2022 (92)
2021 (92)
2020 (65)
Funding
Current Stage
Late StageTotal Funding
$63.31MKey Investors
American Academy of Orthopaedic SurgeonsCalifornia HealthCare FoundationNational Heart, Lung and Blood Institute
2023-12-01Grant· $0.01M
2023-05-25Grant· $28M
2022-06-16Grant· $7M
Leadership Team
Thomas Priselac
President/CEO
David Wrigley
Executive Vice President Finance, CFO and Treasurer
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