In collaboration with the CCTO leadership, the Program Manager will support the growth and development of the Cancer Institute by achieving strategic objectives by overseeing multiple project activities. The Program Manager is responsible for assigned research infrastructure development, oversees projects, communicates status and improvement areas to leaderships and works with leadership team to plan, develop and implement new strategies. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Summary of Essential Job Duties:
Responsible for the oversight and provides support for all aspects of a Research Compliance Program within the Cancer Institute, including development and expansion of training related to quality management, participate in monitoring and remediation of issues identified, assist in auditing, data safety and protocol compliance
Establish data safety monitoring plan that is in line with NCI expectations and FDA regulations. This includes but is not limited to: data safety monitoring committee (DMC), charter, program for safety monitoring of early phase and low risk clinical trials, data safety monitoring board (DSMB), risk-based monitoring program, investigator-initiated trial monitoring, monitoring for affiliate and/or satellite sites,
Establish a robust monitoring plan to ensure compliance and high-quality research at affiliate, satellite and sub-sites (for studies where CSMC serves as the primary site).
Develop and implement staffing models, processes, policies and procedures to sustain a high functioning quality management program that supports CPDM, prevention and control, survivorship, lifestyle intervention and other SOCCI human subject research.
Responsible not for a single research program nor monitor safety in a single facility but monitor compliance of several research projects or research sites.
Coordinates with Legal Department, IRB, Risk management, and other functional areas to enhance policies and systems controls as needed
May be responsible for direct supervision, training and providing support to staff including workload assessment and setting performance standards.
Provides support and guidance to the clinical teams in the development of appropriate corrective & preventative action plans for external audit CAPs such as NCTN, FDA, EMA, etc.
Works closely with training and education lead to identify gaps and provide supplementary education, webinars, training, in-services, policies or procedures to improve clinical research data compliance and overall quality.
Actively lead or assist by serving as the Quality Lead in selected program/teams participating in internal quality audits, corrective action plan assessment (CAPA) and other quality reviews (i.e. IRAP, IMV or audits) as a monitor/auditor
Serves as the QMC point of contact for all external audit notifications (ie., study teams must notify QMC through this position) and facilitates, coordinates and ensures adequate quality management core staffing for all audit preparations.
Demonstrates strong working knowledge of FDA, GCP, IRB and NCI rules, regulations and guidelines. Maintains adequate knowledge of industry trends, GCP regulatory standards and global updates and provides expertise and training sessions to faculty and staff.
Proactively identifies strategic and tactical solutions by providing compliance subject matter expertise. Serves as the Quality expert providing guidance, consultation and expertise to the protocol development core, training and education core, faculty, peers and staff.
Directs the implementation of appropriate strategic/tactical solutions for compliance. Ensures adoption and identifies any outstanding compliance issues. Identifies non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols.
Facilitates the assessment, investigation and tracking of quality issues, quality performance metrics and regularly reports on the overall quality of the program and productivity of QMC. Helps to compile data for external reports.
Leverages E-Systems (i.e. CTMS) to improve efficiencies within the program and ensures systems are in place to ensure timely safety and data reviews as appropriate.
Develop staffing models for the QMC, creates and updates policies and processes for standardization across the DRGs regarding data quality. Communicates new policies and changes to the research staff through routine bulletins and/or work instructions
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research... and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.