"DIRECTOR-CLINICAL RESEARCH OPERATIONS"

DIRECTOR-CLINICAL RESEARCH OPERATIONS

To direct the strategic and operational leadership of clinical research activities within the Clinical Research Support Enterprise (CReSt), ensuring alignment with institutional goals and regulatory standards. To oversee the operational infrastructure that supports research coordination, study start-up, and standardized workflows, while maintaining efficient and compliant processes across all clinical research programs. To manage research facilities and ensure they are equipped and maintained to support diverse clinical trial needs. To lead site-level budget development and contract negotiations with sponsors and vendors, ensuring financial sustainability and adherence to institutional and regulatory requirements. To support investigators, sponsors, and clinical research staff by providing guidance on operational processes, regulatory compliance, and best practices. To cultivate and manage partnerships with UAB and UAB Medicine to expand and enhance clinical research capabilities, leveraging institutional strengths to attract new research opportunities. To identify and implement innovative strategies that improve patient recruitment, data quality, and trial efficiency, while fostering continuous improvement in operational performance.

Job Duties and Responsibilities:

• Lead all aspects of study start-up planning and logistics, including feasibility assessments, site activation, and pre-study meetings.
• Collaborate with investigators and institutional stakeholders to identify and resolve operational challenges and ensure study readiness.
• Serve as a key liaison with sponsors, CROs, federal agencies, and industry partners.
• Oversee research facilities, equipment, and shared resources to support high-quality study conduct.
• Ensure availability and appropriate use of space, staffing, and equipment across all clinical research locations.
• Lead the development, review, and negotiation of clinical trial budgets in partnership with finance teams, PIs, and sponsors.
• Ensure budgets align with institutional policies and accurate cost recovery for study-related procedures.
• Collaborate with legal, contracts, and grants offices to support timely negotiation and execution of clinical trial agreements (CTAs), confidentiality agreements (CDAs), and other related documents.
• Monitor operational performance through metrics and dashboards to identify opportunities for improvement.
• Harmonize operations across all three pillars of CREST, working closely with directors of the other two pillars (Business Operations and Systems and Community Partners and Education) to ensure consistent application of best practices and procedures
• Perform other duties as assigned

Salary Range: $104,045 - $169,075

Qualifications

Bachelor's degree in a related field and ten (10) years of related experience required. Work experience may NOT substitute for education requirement.