Provides oversight for the fiscal management and strategy of clinical research operations for the Department of Surgery, encompassing research compliance, clinical trial contracting, and clinical trial coordination.

1. Provides oversight and management of divisional research (basic and clinical) as well as programmatic grant staff, ensuring quality and success of research endeavors.
2. Works collaboratively with the Office of Research Operations (ORO) Director of Research Finance, ORO finance team, and departmental partners to direct the management and administration of the financial operations of divisional portfolio, including award accounting and contracting issues.
3. Leads efforts to ensure effective team dynamics and teamwork to maximize productivity, ensure researcher and staff satisfaction, and minimize staff turnover while maintaining high quality standards.
4. Collaborates with research staff and leadership as well as other functional groups, across multiple projects, to ensure timelines and financial goals are being met.
5. Initiates, leads, develops and implements process improvement efforts across coverage area.
6. Development and implementation of process improvements and guidelines (including SOPs) for the coverage area, subject to institutional guidelines.
7. In collaboration with the ORO, directs and oversees research functions for the operational area, subject to established institutional developed processes, striving to promote conduct of safe, compliant, and high-quality research.
8. Monitors and analyzes metrics for workload volume, productivity, utilization and other metrics to ensure projects are conducted with optimal efficiency for the operational area.
9. Initiates, leads, develops and implements efforts including training, staff development, process improvements, quality management and other initiatives for the operational area.
10. Collaborates with Faculty Leaders, Directors, Managers, and other functional group key representatives.
11. Monitors and manages budget and quality adherence in research operations for the operational area.
12. Interviews job candidates and makes hiring decisions for positions across divisional research.
13. Actively participates in appropriate divisional leadership meetings, department meetings and organizational meetings.
14. Convenes regular research / advisory committee meetings for the operational area where proposed protocols are presented to the group and divisional decisions are made whether to accept or include a study based on business and scientific evidence.
15. Serves as leadership resource for staff and cross-functional personnel regarding the operational aspects of clinical research for the operational area.
16. Develop budgets and perform operational assessments of Investigator Initiated protocols for the operational area.
17. Performs other duties as required or assigned.

• Master’s degree with 5 years of clinical research, or the equivalent experience required.



• Prior experience supervising staff required.



• A strong clinical research regulatory background required.



• Excellent written and oral communications skills, including ability to speak in front of groups required.



• Knowledge of GCP and FDA research is required.



• Ability to perform regulatory research, interact productively in a wide variety of situations, and command the respect and confidence of broad members, faculty, and research staff required.



• Knowledge of computer databases and general computing software is essential, and experience with clinical trial management system is desired.

• Certification as CCRP through the Society of Clinical Research Associates (SOCRA) or CCRC or CCRA through the Association of Clinical Research Professionals (ACRP) required.