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Job Description

Responsible for directing and managing a specified program within the clinical research operations unit, department, or division. Provides leadership, guidance and direction for the day-to-day clinical research operations and activities, including authority to make independent decisions regarding program operations,
administration, and governance. Ensures compliant, efficient, and effective conduct of the clinical trials within the portfolio. Establishes, implements, and evolves operational standards and monitors quality and progress of the program(s).

Note: A program is an ongoing organizational initiative with defined objectives and scope, but without a defined
end or completion date.

Primary Duties and Responsibilities

• Oversees and/or manages the assigned recognized organizational clinical research program, with authority for day-to-day operations and administration. May develop or expand the program; plans and implements operations; establishes governance, processes, and guidelines; coordinates activities and timelines; and organizes resources to meet objectives.
• May manage study intake, including feasibility, review and endorsement, PRMC submission, and tracking trials declined by program or department leadership.
• Identifies logistics, action items, changes, information needs, and barriers affecting study activation and coordination; participates in implementing solutions. May identify program participants and lead cross-functional teams supporting program administration, maintenance, or expansion.
• Collaborates with internal and external stakeholders, including departments, organizational leaders, and external agencies or organizations, to provide guidance, resolve issues, grow the program, and implement processes or solutions.
• Identifies growth and efficiency opportunities, supports strategic planning, manages study intake and feasibility, and provides recommendations or makes decisions supporting program success. Maintains program growth, community outreach, and stakeholder relationships.
• Researches and analyzes program performance, operations, quality assurance, and trends. Recommends or implements changes and provides findings to participants, stakeholders, leadership, and cross-functional teams. Provides clinical trial oversight, including screening, enrollment, data submission, protocol compliance, and staff training.
• Plans and supports department/program leaders during audits, including preparation and required follow-up.
• Evaluates requests for program exceptions or changes and determines responses, escalating as necessary.
• Assesses communication and training needs; develops and implements communication, education, training, onboarding, and mentorship activities. Provides regular updates to departments and organizational leaders, notifies stakeholders of program changes, and may develop materials with cross-functional teams.
• Partners with leadership to plan, monitor, and manage program budgets and financials and resolve or escalate issues.
• Maintains data system integrity and quality assurance in accordance with departmental standard operating procedures. May provide ad hoc reporting to support trend analysis, recommendations, planning, and enhancements.
• Monitors governance and compliance with local, state, and federal laws; accreditation, professional, and regulatory standards; licensure requirements; and organizational policies and procedures. Monitors compliance reporting tools and provides status reports to the Research Manager and other stakeholders.
• May manage staff and/or lead the work of others, including recruitment, onboarding/offboarding, training, performance management, and professional development.
  

Department-Specific Responsibilities

Additional primary duties and responsibilities performed only within the departments below:

Cancer Clinical Trials Office

• Manages DRG meetings and ensures all information needed to support DRG functions is addressed.
• Communicates regularly with DRG faculty to ensure alignment with DRG needs and future planning. Engages relevant providers—including physicians, advanced practice providers, clinic nurses, and staff—to address clinical issues promptly and compliantly.
• Promotes and advances clinical research activities in a safe, compliant, effective, efficient, and collegial manner.
• Manages and oversees training and education for clinical research staff within the DRG/team. Conducts baseline competency assessments for new hires, identifies development opportunities, and creates training plans following onboarding. Provides ongoing staff development and competency assessments.
• Contributes to the development and execution of educational in-services supporting high-quality clinical research.
• Contributes to corrective action plans and monitors implementation and documentation of progress. Ensures compliance with Cedars-Sinai, CCTO, and SOCCI policies and procedures.
• Actively participates in SOCCI’s strategic planning process for the Cancer Clinical Trials Office.
• Represents the Clinical Trials Office on University/Hospital committees and task forces as assigned. 
• Performs other duties as assigned.

Qualifications

This is an onsite position requiring a minimum of 4 days per week onsite.