Clinical Trials Director


Exemption Status: Exempt
Salary Grade: C10
Job Code: 6127

This is a description of a Staff Position Classification. It is not an announcement of a position opening. To view descriptions of current openings, please go to jobs.ou.edu and Search Postings to view positions that are currently accepting applications.

The following statements are designed to outline the general functions and typical responsibility levels associated with positions in this classification. They are not intended to serve as an exhaustive list of specific duties or requirements for individual positions assigned to this classification.
Essential Duties/Responsibilities:

POSITION INFORMATION: 
Oversees the administrative and operational aspects of clinical research in the Clinical Trials Office (CTO) to include but not limited to policy and procedure development, establishes research priorities and action plans, establishes performance and productivity metrics, serves as liaison, and oversees QA and auditing program. Supervises the senior CTO management team. Develops strategic mission of the CTO.   

REPRESENTATIVE DUTIES  
1. Management. Manages the senior CTO management team.   
2. Policy and Procedure Development. Responsible for the overall development of the policies and procedures of the CTO.   
3. Program Planning. Monitors the global clinical research progress, establishes research priorities, and develops action plans to address clinical research problems.  
4. Program Evaluation. Establishes and monitors performance and productivity metrics for each specialty within the CTO.   
5. Conflict Resolution. Serves as liaison between investigators and sponsors to resolve conflicts related to the conduct of CTO research protocols.   
6. Strategic Planning. Participates in decision-making, programmatic planning and policy issues affecting the CTO.  
7. Cancer Reporting. Collaborates with administration to develop clinical trial reporting in compliance with federal and state requirements.   
8. Staff Communication. Conducts CTO senior management meetings to ensure open communication between CTO employees, senior administration, and physicians.   
9. Quality Assurance (QA). Oversees internal QA and external affiliate auditing program and required action plans.   
10. Informatics. Collaborates with the CTO Informatics Coordinator to develop internal clinical trial management systems to support research regulatory, nursing, and data management, and fulfill federal and state reporting guidelines.   
11. Strategic Financial Planning. Collaborates with the Finance Director and Administration to develop strategic business plan for CTO.   
12. As Needed. Performs various duties as needed to successfully fulfill the functions of the position.


Minimum Requirements:

Education:

Required: Bachelor's egree in Nursing or Health Related Field

Experience:

Required: Minimum seven years clinical research experience with five years in a supervisory role over research regulatory, data management and clinical research nursing cores.

Certifications or Licenses:

  • None

Required Knowledge, Skills, Abilities:

  • Proficient in Microsoft Office


Working Conditions:

Clinical office.