Clinical Research Manager, Research Operations

Job Description 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. The Manager, Research Operations 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. The Manager, Research Operations is accountable to the Department Chair and / or Institute Executive Director and serves as the primary source of information for the department. She / he maintains competency skills including the ability to interact with Faculty and staff within their assigned area, the Medical Center and throughout the Health System. The Manager, Research Operations plans, organizes, manages and controls the daily operations of their area and works closely with departmental leadership, Faculty, Principal Investigators (PIs), staff and students to provide analytical support and project management in fulfilling the established goals and objectives for the department and organization. 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. The Manager, Research Operations 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. Primary Duties and 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. Department-Specific Responsibilities Clinical & Translational Research Center / Science Inst (CTRC / CTSI) 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. Inflammatory Bowel and Immunobiology Research Inst (IBIRI) 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. Neurosurgery 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 participates in the preparation of the annual capital / operations budget as well as monthly reconciliation related to research grant management. Works with the Research Grant Specialist to provide budget and staffing information. Regenerative Medicine Inst (RMI) Reconciles tracked expenses from on-line systems and participates in managing spending and budgeting research grant monies. 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. Emergency Medicine Research 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. Qualifications REQUIREMENTS Bachelor’s Degree in Business, Administration, Nursing, or equivalent work experience required 5 years of related supervisory or management experience, with increasing responsibility Preferred Qualifications : Master’s Degree (MBA or MPH) strongly preferred 2 years of experience in finance or budget oversight. Knowledge of general accounting and financial analysis. Knowledge of GAAP rules helpful Req ID : 12570 Working Title : Clinical Research Manager, Research Operations Department : Cancer - SOCCI Clinical Research Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Academic / Research Services Overtime Status : EXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $55.31 - $96.79