Director of Administration, Cancer Clinical Trials Office

Required Qualifications (as evidenced by an attached resume):

Master's degree (foreign equivalent or higher) in Healthcare Administration (MHA), Public Health (MPH), Business (MBA), or a related field. Seven (7) years of full-time progressive leadership experience in clinical research administration. Five (5) or more years of full-time experience specifically within an Oncology setting. Experience managing large teams (30+ FTEs).

Preferred Qualifications:

CCRP, CCRC, or SoCRA certification. Direct experience working within an NCI-designated Cancer Center, specifically assisting with a CCSG renewal or initial application. Deep familiarity with OnCore CTMS and NCI reporting requirements (Data Table 4).

Brief Description of Duties:

The Director of Administration serves as the senior administrative leader for the Cancer Clinical Trials Office (CCTO). This role is responsible for the strategic direction and operational management of all clinical cancer research activities. Crucially, the Director of Administration will partner with the Medical Director to lead the initiative to achieve NCI Designation. This position requires a visionary leader capable of building the robust infrastructure, policy framework, and data reporting systems required by the NCI's Cancer Center Support Grant (CCSG) guidelines.

Duties:

Strategic Leadership & NCI Designation Readiness:

• CCSG Preparation: Lead the administrative planning and preparation for the CCTO related portions of the NCI Cancer Center Support Grant (CCSG) application, ensuring all Clinical Protocol and Data Management (CPDM) standards are met or exceeded.
• Strategic Planning: Develop and execute a 3 - 5 year strategic plan to scale trial volume, increase accrual to therapeutic trials, and enhance the diversity of patient participants.
• Governance: Serve as a key member of the Cancer Center's clinical research leadership team, advising on resource allocation, space planning, and staffing models required to support growth.

Operational Management:

• Workflow Optimization: Oversee all centralized core functions including patient screening/enrollment, data management, regulatory affairs, quality assurance, and trial activation.
• Timeline Reduction: Implement process improvements to significantly reduce study activation times (open-to-accrual timelines) and streamline protocol amendments.
• SOP Development: Establish and maintain comprehensive Standard Operating Procedures (SOPs) that ensure compliance with GCP, FDA, OHRP, and institutional policies.

Regulatory & Quality Assurance:

• Audit Readiness: Direct the internal Quality Assurance (QA) unit to conduct routine monitoring and audits; serve as the primary point of contact for external audits (NCI-CTEP, FDA, Sponsors).
• DSMC Support: Provide administrative oversight for the Data and Safety Monitoring Committee (DSMC) to ensure patient safety and data integrity.
• PRMC Support: Provide administrative oversight for the Protocol Review and Monitoring Committee (PRMC).
• Compliance: Ensure strict adherence to federal and state regulations regarding human subjects protection and HIPAA.

Informatics & Reporting:

• CTMS Management: Oversee the optimization and utilization of the Clinical Trial Management System (CTMS) (e.g., OnCore) to ensure accurate data capture for the NCI Data Table 4 reporting.
• Data Integrity: Ensure high-quality data collection for seamless integration with the center's Electronic Medical Record (Cerner).

Personnel Management:

• Oversee the management of all CCTO staff (with mid-level leaders), ensuring optimal FTE levels, appropriate coverage for all units, and appropriate planning for future needs.
• Ability to lead teams through significant organizational growth and cultural shifts.
• Ability to build consensus among diverse stakeholders, including physician-investigators, hospital administration, and external sponsors.
• Proficiency in using metrics and KPIs to drive operational performance.
• Other duties as assigned