Provides senior administrative management to the clinical trials program by negotiating contracts with sponsoring funding agencies, preparing and submitting applicable regulatory filings, planning and controlling the budget, supervising the clinical trials staff, engaging in marketing communications and strategies to raise revenues and awareness for programs, and acting as a liaison with other departments/organizations.

• Provides direct administrative and fiscal management of the program(s) and related grants. 
• Manages the day-to-day business operations of the program. 
• Responsible for overseeing, planning, and monitoring of strategic plans.
• Manages and implements new workflows and processes.
• Responsible for fiscal oversight and management to include decisions regarding appropriate rates within University approved salary ranges for new hires, increases and promotions of existing staff, and approval of purchases such as supplies and equipment. 
• Responsible for financial planning of the program(s) and monitoring progress. 
• Develops and manages the program(s) budget. 
• Ensures the fiscal viability of programs and advises medical and college/department leadership on long-range financial planning and development of new initiatives. 
• Develops budgets for all grant submissions
• Ensures staff correctly identifies patients who may be eligible to participate in the clinical trial, and the initial assessment of potential patients is completed, including the patient's clinical history, a physical exam, the patient data form is correct, and a consent form from each patient is received.  
• Responsible for conducting ongoing assessments of outreach and timelines to determine needed services, funds, and staffing.
• Ensures clinic staff and other departments are made aware of new regulatory processes, workflows, and standards.
• Networks with other institutions and applicable research partners to learn and share best practices and improve internal processes.
• Builds and maintains community relationships with outside physicians, other health care organizations, and serves as referral resource for non-CTO staff and investigators.
• Ensures completion of all aspects of study start up, continuing review, and study close-out are complete from a regulatory perspective.
• Manages clinical trials data and performs data analysis. 
• Establishes and maintains reporting metrics and operational functions.
• Attends and presents clinical trial information at various meetings.   
• Supervises assigned staff to include hiring, training, scheduling workloads, evaluating, and terminating employees. 
• Ensures all employees adhere to institutional policies and procedures while ensuring federal regulations are met.
• Performs various duties as needed to successfully fulfill the function of the position.

Education:

Required: Bachelor's Degree in health-related field to include Health Administration, Public Health, Nursing, or close related field.

Experience:

Required: 48 months experience in clinical trials research coordination and/or administration, professional level data management and analysis, or other closely related professional level role.

Certifications or Licenses:

• None

• Proficient in Microsoft Office

Physical:  Sitting for long periods of time.  Speaking and listening.  Manual dexterity.

 Environmental:  Office Environment.