Senior Manager, Research Operations - The Angeles Clinic & Research Institute

Cedars Sinai•Los Angeles, CA

41d•$57 - $95

About The Position

Join Cedars-Sinai! Cedars-Sinai Medical Center has been named to the Honor Roll in U.S. News & World Report's "Best Hospitals 2024-2025" rankings. Align yourself with an organization that has a reputation for excellence! Cedars Sinai was awarded the National Research Corporation's Consumer Choice Award 19 years in a row for providing the highest-quality medical care in Los Angeles. We also were awarded the Advisory Board Company's Workplace of the Year. This recognizes hospitals and health systems nationwide that have outstanding levels of employee engagement. Join us! Discover why we have been recognized nine years in a row on the "Best Hospital" Honor Roll by U.S. News & World Report. The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all our patients with cancer. Why work here? Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for. Join our team and contribute to groundbreaking research. The Senior Manager, MN Research Operations provides strategic leadership to the clinical, regulatory, and financial units of the assigned CRO. Directs managers/supervisors assigned to these units within the CRO by establishing and implementing operational standards and monitoring progress and compliance. Serves as the subject matter expert on best practices on clinical trial management, regulatory requirements. Responsible for the strategic expansion and ongoing achievements of the CRO, in partnership with the Director of Operations and Medical Director.

Requirements

Bachelor's degree in related field.
5 years of experience in clinical research required.
4 years of managerial level experience required. Evidence of progressive leadership experience.

Nice To Haves

Master's degree in Science or related field preferred.
Knowledge and/or experience with NCI CCSG expectations is preferred.
Previous experience coordinating and managing oncology clinical research programs preferred.

Responsibilities

Responsible for the strategic planning, organizing, and oversight of the TACRI CRO including the development of strategies for patient recruitment, compliance, performance and quality improvement, operational efficiency, and employee engagement.
Ensures the development of TACRI's clinical research infrastructure that supports the clinical research community and is consistent with expectations of NCI-designated Cancer Centers as outlined in the Cancer Center Support Grant (CCSG) guidelines. Ensures that all institutional, local, state, and Federal Regulations, Good Clinical Practice (GCPs), ICH, and IRB requirements are met and that all research programs within TACRI are structured to continue to meet these expectations.
Supervises a team of highly skilled and efficient clinical research staff charged with upholding the same expectations and requirements including continued focus on increasing efficiencies, improving quality control, and providing a robust training and education program. Provides expertise, guidance, and oversight to the operational units within the CRO (clinical, regulatory, finance, quality, training, information systems, etc.).
Supports the implementation and/or maintenance of requirements as outlined in the National Cancer Institute's, Cancer Center Support Grant guidelines relative to all clinical research requirements (i.e. Clinical Protocol and Data Management, Accrual of Women and Underrepresented groups to clinical trials and associated Data Tables).
Supervises the development, implementation, and updating of standard operating procedures (SOPs) to ensure consistent, safe, and efficient management of clinical trials and continuous improvements in the fiscal integrity of clinical research activities.
Administrative management of the electronic systems used to monitor CRO performance and efficiency and participation in the development or the selection of institutional systems that would impact the CRO operations and conduct of clinical research in the TACRI.
Provides oversight for generation of monthly reports including but not limited to CRO performance, accrual, monitoring, time to activation, audit visits, and financial performance. Ensure accuracy of clinical trial information in all CTMS, clinical trial databases, and tracking systems. Ensure quality, timely, and accurate data and report submission.
Assists in the growth of TACRI clinical research program throughout Cedars-Sinai Cancer Network and Affiliate sites alongside institutional leadership.
Integration of Cedars-Sinai and the TACRI central research administration initiatives and serve as a pilot for expanding clinical research support services enterprise-wide as appropriate.
Represents the TACRI CRO on Health System committees and task forces. Serves as liaison to advance clinical research interests including participation in community outreach.
Oversees financial resources, development, and management of clinical trials budgets; and in conjunction with the Executive Director of the CRO and TACRI Finance Director prepare, monitor, and forecast the CRO annual operations budget.
Responsible for the full range of supervisory functions, including assessing staffing needs; interviewing and evaluating candidate qualifications; hiring and onboarding new team members; maintaining and enhancing staff competence through ongoing training and development; assigning and reviewing work; evaluating performance; recommending compensation actions; and administering disciplinary measures up to and including termination of employment, in accordance with organizational policies and procedures.
Serves as an effective leader by fostering a positive and supportive work environment that encourages self-directed staff, promotes professional growth and contribution, and applies human resource policies fairly and consistently.