The Dan L Duncan Comprehensive Cancer Center (DLDCCC) at Baylor College of Medicine is a leader in the genomics and proteomics of cancer and pioneered the science leading to optimal hormonal and other targeted therapies, as well as the immunotherapeutic treatment of cancer using CAR T cells. The DLDCCC provides compassionate patient care and cutting-edge research through four hospital partners: Baylor St. Luke’s Medical Center, the Michael E. DeBakey Veterans Affairs Medical Center, Ben Taub Hospital, and Texas Children’s Hospital. Our mission is to reduce morbidity and mortality from cancer through research, education, and community outreach. Since 2007, we have enrolled more than 5,400 patients into clinical trials.
We have an immediate opening for the Administrative 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 rapidly, and we are looking for a dynamic, experienced administrative director to guide growth and operations. The Administrative 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 CTSU research teams including Regulatory, Research Coordinator, Finance, and QA/QC. The directors and managers for each team report 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 development of processes for operational conduct and prioritization of clinical research studies within the CTSU
Provides leadership and guidance for day-to-day activities of the 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 Patient Safety Officer and oversight committees
Supervises the OnCore Administrator, 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 QA team to maintain and/or develop institutional clinical research standard operating procedures and new employee training
Collaborates with quality assurance and finance teams to drive operational improvement to increase effectiveness
Assists investigators with development of clinical trials protocols
Also required:
Attendance at national meetings to stay abreast of current best practices
Experience with multi-site trials strongly preferred
Strong knowledge of clinical research regulations, and an understanding of regulatory, finance, QA/QC, and operational aspects of clinical research
Minimum Qualifications
Bachelor’s degree
Eleven years of directly related experience with four years of supervisory experience
Preferred Qualifications
Master’s degree or Ph.D.
CCRP or comparable certification
Experience with NCI CCSG requirements
Experience with OnCore or other CTMS systems
Please apply at https://jobs.bcm.edu/job-invite/13320/