Director Research

The Director of Clinical Research Operations provides strategic, operational, and personnel leadership for the clinical research workforce across Cooper's research enterprise. This position is responsible for directing the operational execution of clinical trials and human subject research activities conducted by centralized Office of Research and Sponsored Programs (ORSP) research coordinators and research nurses, while also providing leadership, consultation, oversight, and operational guidance to decentralized research teams embedded within clinical departments, institutes, and specialty programs.Working under the direction of the AVP of Research Operations and Support Services, the Director develops, implements, and maintains standardized research operations, staffing models, quality programs, workforce development initiatives, and performance expectations that support compliant, efficient, and scalable clinical research operations across the organization.The Director serves as a key operational partner to investigators, physician leaders, institute administrators, nursing leadership, regulatory teams, finance, and support service departments to ensure research activities are conducted in accordance with institutional policies, Good Clinical Practice (GCP), sponsor requirements, applicable federal regulations and state laws.

Provide direct leadership of day-to-day research operations among the centralized ORSP Clinical Research Coordinators, Research Nurses and associated staff, while establishing and maintaining a collaborative framework for supporting decentralized research staff operating within clinical departments and specialty programs to ensure staff, workload distribution and resource allocation is standardized and in line with best practice regardless of reporting structure, optimized staffing models and operational performance.Create mechanisms for centralized support, shared services, mentorship, and operational consultation for decentralized teams.Develop and oversee quality assurance and operations of clinical research activities to ensure alignment with institutional policies, IRB requirements, federal regulations (e.g. FDA), GCP standards, state law and sponsor expectations; while supporting organizational readiness for sponsor audits, FDA inspections and internal assessments and partnering with the necessary teams to address findings and implement corrective actions.

Manage and analyze operational and quality metrics, performance dashboards and stakeholder feedback to identify opportunities for improvement, monitor productivity and resource utilization; support growth, efficiency, and regulatory compliance for continuous improvement.Recruit, coach and retain high performing research professionals and foster a culture of accountability, collaboration and continuous improvement within the team(s) and within each staff member.Lead development and implementation of standardized workflows, SOPs, guidance documents and operational tools, including core clinical research processes, across centralized and decentralized research teams, where appropriate.Serve as a primary liaison for partnership with research/institute leadership, clinical departments, physician investigators, regulatory personnel, finance teams and support teams to manage clinical trial operations, strategic planning initiatives, such as new research initiatives, feasibility assessments and program development activities.Support with implementation and lead optimization efforts related to research technology platforms including CTMS, eSource, Epic Research, participant payment systems, and other research applications.

Participate in strategic planning initiatives to support institutional research priorities and growth.Assist with development and management of operational budgets related to staffing and resource allocation with financial sustainability and operational efficiency in mind.

6-10 Years Required

Master's Degree Required

Health Sciences, Public Health, Research Administration, Healthcare Administration, or related field.