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

Cedars-Sinai•Los Angeles, CA

About The Position

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. 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.

Responsibilities

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.