Clinical Research Facilitation Director - Sponsored Programs Administration - Post Award
Department: Pst Awrd Admin
Full/Part Time/PRN: Full-Time
Experience and Education
2.Facilitate timely and appropriate communication with Principal Investigators and Research Nurses/Coordinators on all aspects of clinical research administration.
3.Lead continuous process and operational improvement initiatives to reduce cycle-times, improve overall compliance posture, and remove unnecessary administrative burdens. Ensures the office will provide knowledgeable, friendly, professional, and timely support to clinical research community.
4.Oversee the clinical trial coverage analyses process and reviews, contract development, and budget negotiation for industry-funded clinical trials and complex non-industry clinical trials.
5.Oversee the development and maintenance of the institutional clinical trial management system. Oversee the process to register all clinical trials within the institutional clinical trial management system and, as necessary, with federal clinicaltrials.gov registry and within institutional clinical trial registries.
6.Participate and/or facilitate discussions around the integration between the institutional clinical trial management system and other sponsored award management systems, specifically PeopleSoft and eGrants (Click solution).
7.Oversee the process to register all clinical trial participants within the institutional clinical trial management system and, as necessary, with affiliated electronic medical record systems.
8.Ensure that clinical research income is billed in a timely manner, received timely, and accounted for accurately in institutional financial systems.
9.Serve as the primary UTSW point of contact with affiliate institutions on clinical trial needs, working continually to improve processes and services to ensure limited to no disruption in clinical services. This includes ensuring that invoices from affiliate institutions are reviewed, tracked, and paid timely.
10.Establish key operational metrics, publish periodic performance reports to research community, maintain maximum efficiency, and meet performance objectives.
11.Implement and oversee an ongoing educational and training program for faculty and staff relating to conducting clinical research in partnership with Research Administration.
12.Establish and maintain policies and procedures related to clinical research billing compliance. Ensures compliance with applicable laws, regulations, policies, and procedures.
13.Oversee supervisors and/or subordinate managers, including establishing priorities.
This Director position oversees our Clinical Research Services team which includes Coverage Analysis and the Clinical Research Agreements. The Director is involved with systems utilization such as Velos, eIRB and Greenphire, and is to enable and support compliance in clinical research and with research participants. This position ensures clinical research income is billed, received and accounted for timely and accurately for the institution. Serves as the primary contact for UTSW with affiliates on clincial trial needs and works to ensure sound and effective relationships with study sites.
The Director also support the CTSA grant and participates in necessary meetings to support the CTSA PI.
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; gender, including sexual harassment; age; disability; citizenship; and veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.