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).

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 Primary Duties and Responsibilities 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, onboarding/off-boarding, training, performance management and professional development of staff.

Department-Specific Responsibilities 

• Manage Disease Research Group (DRG) Meetings: Lead and coordinate DRG meetings, ensuring that all necessary information is addressed to support DRG functions. Maintain regular communication with DRG faculty to ensure alignment with DRG needs and future planning.
• Clinical Issue Resolution: Engage with providers (physicians, advanced practice providers, clinic nurses, and staff) to ensure that clinical issues are identified and addressed promptly and in compliance with policies.
• Promote Research Excellence: Advance clinical research activities in a safe, compliant, effective, efficient, and collegial manner.
• Training and Development:
• Oversee the training and education of clinical research staff within the DRG/team.
• Conduct baseline competency assessments for new hires, identify areas of opportunity, and develop individualized training plans.
• Provide ongoing management of staff development, including competency assessments and continued education opportunities.
• Contribute to the development and delivery of educational in-services to ensure high-quality clinical research performance.
• Compliance and Quality Oversight:
• Contribute to the development and monitoring of corrective action plans.
• Ensure compliance with Cedars-Sinai, CCTO, and SOCCI policies and procedures.
• Strategic Leadership: Actively participate in the strategic planning process of SOCCI?s Cancer Clinical Trials Office (CCTO). Represent the CCTO on university and hospital committees and task forces as assigned.
• Clinical Study Coordination:
• Independently coordinate studies, including patient screening, informed consent (when IRB- and Nursing Institute-approved), and oversight of study assignments within the group.
• Supervise research staff and ensure compliance with federal and local regulations, including FDA and IRB requirements.
• Develop and implement strategies to increase patient enrollment, improve efficiency, train personnel, and identify new research opportunities.
• Specimen and Clinical Services:
• Coordinate study participant tests and procedures as required, and handle research specimens (processing, shipping, tracking).
• Perform phlebotomy services in accordance with CSMC policies and procedures, ensuring accurate specimen labeling and reporting of results.
• Other Duties: Perform additional responsibilities as assigned to support departmental goals.

Required Qualifications

• High School Diploma or GED.
• Minimum 5 years of experience in management, program/project management, or a related field.
• Minimum 3 years of experience in a clinical research or related industry setting.
• Demonstrated experience managing a team, including direct supervision of staff, in a clinical research setting.
• Familiarity with clinical research operations, including regulatory compliance, study coordination, and staff development.

Preferred Qualifications

• Bachelor?s degree in healthcare, management, or a related field.
• At least 1 year of experience managing clinical trial operations.