The Dan L Duncan Comprehensive Cancer Center (DLDCCC) has an immediate opening for the Director of the Clinical Trials Support Unit (CTSU). This position works closely with the Associate Director of Clinical Research, to provide leadership for all aspects of the conduct and oversight of clinical research. The DLDCCC clinical research enterprise is growing fast, and we are looking for a dynamic, experienced administrative director to guide our growth and operations. The Director is expected to work collaboratively with a wide variety of faculty and staff within the DLDCCC, and should have adequate experience to provide leadership for the CTSU team. The Director supervises all CTSU research teams including Regulatory, Research Coordinator, Finance, and QA/QC. The Directors and Managers for each team are direct reports to this position.Job Duties
- Works with DLDCCC Leadership on CCSG grant and required reporting.
- Works with DLDCCC Leadership to guide the structure, policies, and practices of the CTSU.
- Assists with the development of processes for operational conduct and prioritization of clinical research studies within the CTSU.
- Provides leadership and guidance for the day-to-day activities of the entire CTSU office. Serves as liaison with the Investigators and Disease Working Group members regarding clinical trial operations
- Provides analytical and oversight support for the regulatory review committee
- Supervises the DLDCCC Patient Safety Officer and the oversight committees
- Supervises the OnCore Administrator, and works closely with the bioinformatics OnCore support team and is responsible for ensuring the NCI CTRP reporting is current and accurate.
- Facilitates clinical trial feasibility to ensure cost effectiveness and operational ability.
- Works with Quality Assurance team to maintain and/or develop institutional clinical research standard operating procedures and new employee training.
- Collaborates with the quality assurance and finance team members to drive operational improvement to increase effectiveness.
- Assists investigators with development of clinical trials protocols
- Attendance at national meetings to stay abreast of current best practices.
- Experience with multi-site trials is strongly preferred.
- Strong knowledge of clinical research regulations, and an understanding of regulatory, finance, QA/QC, and operational aspects of clinical research.
- Bachelor's degree.
- Eleven years of directly related experience with four years of supervisory experience.
- Master's degree or Ph.D.
- CCRP or comparable certification
- Experience with NCI CCSG requirements
- Experience with OnCore or other CTMS systems
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
CA; CH; SN