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 and has authority for day-to-day program operations and administration. May be responsible for program development or expansion. Plans and implements program operations, determines and develops governance, processes and/or guidelines, coordinates program activities and timelines, and determines and organizes resources to meet program objectives.
• May manage the research study intake process, including feasibility, review and endorsement and PRMC submission, as well as capturing all trials declined by program or department leadership.
• Identifies and defines any logistics, action items, changes, or information needed to effectively manage the program. Identifies barriers to timely study activation, efficient coordination, and participate to identify/implement potential solutions. May identify program participants and lead cross-functional teams in the administration, maintenance or expansion of the program.
• Interfaces with internal and external key stakeholders including other departments, leaders across the organization, representatives from external agencies/organizations in the management of the program to provide guidance, resolve issues, grow the program, and/or implement processes and/or solutions.
• Identifies growth opportunities and further efficiencies that impact the program and/or departments success and aids in development of strategic plans to achieve objectives. Manages study intake process, evaluates feasibility, and providing recommendations or making decisions to support the success of the clinical research program. Interfaces with internal/external stakeholders to maintain and further develop program growth, community outreach activities, as well as relationship building and maintenance.
• Researches and analyzes data for evaluating performance of program or program operations, including quality assurance and trends. Makes recommendations to leadership and/or implements program changes based on findings. Provides data and/or summary findings to program participants, stakeholders, leadership, and/or cross-functional teams. Performs quality oversight of clinical trials to include monitoring progress of screening, enrollment, and data submission. Responsible for ensuring protocol compliance and training of staff supporting the program.
• Plans and supports the department/program leaders during an audit, to include direction for audit prep and any required follow up post audit.
• Evaluates requests for program exceptions or changes, and determines response, escalating as necessary.
• Assesses communication and training needs, develops and implements any applicable communication, education, training, on-boarding and/or mentorship pertaining to the program. Provides regular communication to departments and leaders across the organization. Notifies stakeholders of any changes to the program. May work with cross-functional teams across multiple departments to develop communication and training materials.
• In conjunction with leadership, responsible for planning, monitoring, and managing program fiscal budgets and financials, and resolves or escalates issues.
• Maintains data system integrity and ensures quality assurance measures are followed based on departmental standard operating procedures. May provide ad hoc reporting to support recommendations observed through trend analysis for future planning and enhancements.
• Monitors program to ensure appropriate governance and program compliance with local, state and federal laws; accreditation, professional and regulatory agency standards and licensure requirements. Maintains staff and program compliance with organizational policies and procedures. Monitors compliance reporting tools and provides summary status reports to the Research Manager, and other stakeholders.
• May manage staff and/or lead the work of others, including some or all of the following: recruitment, on-boarding/off-boarding, training, performance management and professional development of staff.

Department-Specific Responsibilities

• Manage DRG meetings and ensuring that all necessary information to support the function of the DRG are addressed.
• Communicate regularly with DRG faculty to ensure alignment with DRG needs and future planning. Engage relevant providers (physicians, advance practice providers, clinic nurses, staff) to ensure that clinical issues that arise, at all points of contact, are addressed in a timely and compliant fashion.
• Promote and advance the clinical research activities in a safe, compliant, effective, efficient, and collegial manner.
• Other duties as assigned.
• Manage and oversee the training and education of clinical research staff within the DRG/team. Conducts baseline assessment of new hire competencies, identification of areas of opportunity, and development of training plan for each staff member once onboarded as well as identification of opportunities for continued education opportunities and growth. Provides ongoing/routine management of staff development including competency assessment.
• Contributes to the development and execution of educational in-services pertinent to the performance of high-quality clinical research.
• Contribute to the development of corrective action plans, monitor subsequent implementation and documentation of progress of plans. Ensure compliance with Cedars-Sinai, CCTO and SOCCI policies and procedures.
• Actively participates in the strategic planning process of SOCCI’s Cancer Clinical Trials Office. Represents the Clinical Trials Office on University/Hospital committees and task forces as assigned.

Requirements:

• High School Diploma or equivalent experience/GED
• 5 years Management, Program or Project Management, or related experience
• 3 years of related experience within Oncology clinical research or Oncology research industry setting.

Preferred:

• Bachelor's Degree in Healthcare, Management, or related field
• 1 year of experience managing the operations of a clinical trial

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