Directs research administration for a large department and is directly responsible for financial planning activities. Provides professional expertise in the complex areas of sponsored research contracts and agreements, subcontracts, clinical trial agreements, and material transfer agreements. Responsible for supervision of a highly functioning Clinical Trials Office.
1. Works with the institutional Office of Sponsored Programs to negotiate clinical trial agreements, grant funded clinical research, and confidentiality agreements for the Mays Cancer Center.
2. Primary contact for institutional offices including, Accounting, Sponsored Programs, Office of Clinical Research, Research Imaging Institute, and the Institutional Review Board in relation to clinical research.
3. Works with faculty and clinical leadership at Mays Cancer Center to ensure seamless integration of clinical and research missions.
4. Assists faculty with resourcing clinical research studies and counsels on the unique requirements of each study.
5. Oversee operations of the Clinical Trials Office in collaboration with the leadership team to ensure optimal operations.
6. Manages subcontracts and consultancies with other national/international academic institutions; liaises as appropriate with Industry and granting agencies who have awarded grants to the Institute for clinical research studies.
7. Monitors resource allocations and ensures that funds are used in accordance with external sponsors’ policies and university policies.
8. Keeps faculty and leadership within the institute informed of Clinical Trials Office status- including staffing, accruals to studies, and new workflows.
9. Assists with the preparation and submission of progress reports for funding agencies.
10. Designs workflows and monitors protocol adherence for ongoing research projects.
11. Ensure compliance with all internal and external regulatory requirements including NIH reporting requirements, IRB proposals, annual renewals, and protocol amendments.
12. Collaborates with the Quality Assurance and Training Division to respond to audit trends, and develop corrective action plans to address deficiencies identified and new policies and procedures.
13. Works collaboratively on process improvement projects with clinical and research leadership.
14. Assists with developing annual budget projections for the Clinical Trials Office and provides quarterly financials to each of the Cancer Center's Clinical Disease Site Teams.
15. Oversees semi-annual reporting processes.
16. Orients faculty to institutional research policies and procedures.
17. Management duties include interviewing, selecting, and training employees; setting and adjusting pay rates and hours of work; planning and directing work; appraising productivity and efficiency, handling complaints/grievances and disciplining when necessary.
18. Performs all other duties as assigned.
Bachelor's degree is required; a Master's degree is highly preferred.
Nine (9) years of experience in clinical research or related administration is required, or seven (7) years of experience with a Master's degree is preferred. A minimum of five years of supervisory experience in clinical research is preferred.