Director, MN Research Operations - The Angeles Clinic & Research Institute

Cedars-Sinai Medical Center•Los Angeles, CA

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 Director, MN Research Operations is responsible for providing overall administrative leadership and operational management of clinical research and initiatives for assigned departments. Under the direction of the Vice President, Strategic Integration and the Cedars-Sinai Medical Group (CSMG) Research Steering Committee and Advanced Heart Disease Research Committees, the position oversees clinical research trials, demonstrating expertise in a variety of fields related to the conduct and management of a robust and vibrant clinical research portfolio which encompasses all study phases. This includes seeking out clinical trial opportunities and working with physician-investigators, staff and external research sponsors to promote collaboration and quality science, while ensuring financial stewardship of resources. The director is responsible for ensuring adherence to Cedars-Sinai Research standard operating procedures, ICH/GCP guidelines, FDA regulations, and all other state or local regulatory requirements or standards of practice. The Director demonstrates strong project planning, leadership, negotiation and presentations skills as well as an ability to contribute practical solutions to problems. This includes driving processes to ensure that institutional research objectives are met and that ethical obligations to research subjects are met. Identifies and develops resources, sets direction and priorities for the department, prioritizes program resource investments, positioning the program and department as a leader in its specialty. Builds strong internal networks across the organization, creating strategic alliances/partnerships to support program expansion. Represents the Medical Network to the Cedars-Sinai Medical Center (CSMC) clinical and surgical departments and the Cedars-Sinai Office of Research Administration to identify and implement opportunities to enhance research, including evaluating existing programs and developing business plans for programs with growth potential. Identifies, pursues, and secures opportunities for research program development and growth. Evaluates and optimizes clinical research staff performance, compliance, and resource utilization. Implements growth, cost-reduction, physician wellness, patient experience, academic standing and/or other initiatives in support of the organization’s strategy. Develops, deploys, and revises Standard Operating Procedures (SOPs) as necessary to (1) proactively detect, eliminate and prevent regulatory compliance issues, (2) minimize institutional risk, (3) improve research subject safety and (4) maximize cost recovery. Provides critical financial and operational analysis for actionable recommendations for department strategic and operational plans. Leads implementation of action plans. Guides the successful integration of the research program(s) across other areas of the organization and affiliated organizations. Facilitates the development of investigator-initiated protocols for internal funding and external grant requests, including NIH submissions. Reviews or consults on all clinical trial protocols submitted for Institutional Review Board evaluation and approval. Oversees the creation and implementation of internal monitoring processes. Provides leadership and oversight in the monitoring of trial data. Participates in preparation for external audits, meets with external auditors, and leads resolution of any identified issues. Explores methods to reduce the number of deviations and findings and implements training to ensure compliance with all corrective action plans. Facilitates grants and contracts process, supports protocol billing, provides oversight for Medicare Coverage Analysis as required.

Requirements

Bachelor’s degree in healthcare administration, business administration, biological science or related field
10 years of progressive experience in clinical program or clinical research program development and/or management
5 years of experience in management or leadership of staff

Nice To Haves

Master's degree preferred.
Experience in academic setting preferred.

Responsibilities

providing overall administrative leadership and operational management of clinical research and initiatives for assigned departments
oversees clinical research trials, demonstrating expertise in a variety of fields related to the conduct and management of a robust and vibrant clinical research portfolio which encompasses all study phases
seeking out clinical trial opportunities and working with physician-investigators, staff and external research sponsors to promote collaboration and quality science, while ensuring financial stewardship of resources
ensuring adherence to Cedars-Sinai Research standard operating procedures, ICH/GCP guidelines, FDA regulations, and all other state or local regulatory requirements or standards of practice
Identifies and develops resources, sets direction and priorities for the department, prioritizes program resource investments, positioning the program and department as a leader in its specialty
Builds strong internal networks across the organization, creating strategic alliances/partnerships to support program expansion
Represents the Medical Network to the Cedars-Sinai Medical Center (CSMC) clinical and surgical departments and the Cedars-Sinai Office of Research Administration to identify and implement opportunities to enhance research, including evaluating existing programs and developing business plans for programs with growth potential
Identifies, pursues, and secures opportunities for research program development and growth
Evaluates and optimizes clinical research staff performance, compliance, and resource utilization
Implements growth, cost-reduction, physician wellness, patient experience, academic standing and/or other initiatives in support of the organization’s strategy
Develops, deploys, and revises Standard Operating Procedures (SOPs) as necessary to (1) proactively detect, eliminate and prevent regulatory compliance issues, (2) minimize institutional risk, (3) improve research subject safety and (4) maximize cost recovery
Provides critical financial and operational analysis for actionable recommendations for department strategic and operational plans
Leads implementation of action plans
Guides the successful integration of the research program(s) across other areas of the organization and affiliated organizations
Facilitates the development of investigator-initiated protocols for internal funding and external grant requests, including NIH submissions
Reviews or consults on all clinical trial protocols submitted for Institutional Review Board evaluation and approval
Oversees the creation and implementation of internal monitoring processes
Provides leadership and oversight in the monitoring of trial data
Participates in preparation for external audits, meets with external auditors, and leads resolution of any identified issues
Explores methods to reduce the number of deviations and findings and implements training to ensure compliance with all corrective action plans
Facilitates grants and contracts process, supports protocol billing, provides oversight for Medicare Coverage Analysis as required