The Associate Director of Clinical Research Office (CRO) Administration at the Harold C. Simmons Comprehensive Cancer Center serves as a leader in the Center with the primary responsibility of high quality, safe and compliant conduct of oncology clinical trials throughout the SCCC. This position involves oversight of a 120+ person clinical research office and will report to the Director of SCCC Clinical Research Operations.
As a key component of an NCI Designated Comprehensive Cancer Center, the CRO oversees the submission and conduct of more than 400 active clinical trials averaging more than 1000 clinical trial enrollments per year. We proudly support diversity initiatives among staff, and we prioritize diversity and inclusion in clinical trial enrollment with nearly 40% of our patients enrolled representing racial and ethnic minorities.
Fundamental priorities of this individual will be to execute the priorities of the Cancer Center Support Grant and the SCCC Director as it relates to clinical trials and the operation.
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EXPERIENCE AND EDUCATION
· Master’s degree in related field required, with at least 7 years of experience managing clinical trials.
· Experience managing oncology clinical trials strongly preferred.
· Work under limited supervision to develop, implement, oversee, and evaluate all administrative, financial, and oversight functions associated with all oncology clinical trials at the Simmons Comprehensive Cancer Center.
· Develop and maintain peer-level working relationships with faculty and academic departments across UTSW to oversee the conduct of oncology clinical trials. Direct and manage all research nursing and technical staff that manage clinical oncology trials and supervise the organization and functions of all Disease Oriented Teams (DOTs) which are chaired by faculty.
· Oversee the financial and administrative resources available for the management of clinical oncology trials on campus, working closely with staff and faculty from multiple academic departments.
· Ensure that the Data and Safety Monitoring Committee (DSMC) and Protocol Review and Management System (PRMS) are functioning in accord with national standards.
· Responsible for ensuring the proper conduct and oversight of all oncology clinical trials on the UTSW campus.
· Develop and maintain a productive and efficient working relationship with Parkland Health and Hospital System, Children's Medical Center, and other affiliates. Negotiate contracts and agreements with those entities to ensure that oncology clinical trials are open and accruing with those research partners in a timely, efficient and safe manner.
· Collaborate with Academic Information Systems (AIS) leadership to ensure that the development, implementation, and ongoing use of the clinical trials management system progresses satisfactorily, and work closely with AIS leadership to address issues, ensuring that the system is accurately and efficiently managing oncology clinical trials.
· Maintain relationships with and participate in national organizations (e.g., American Association of Cancer Institutes, Eastern Cooperative Oncology Group, National Cancer Institute, Clinical Trials Reporting Program) and working groups associated with oncology clinical trials in order to monitor and ensure compliance with NCI-guidelines pertaining to the conduct, oversight and management of clinical trials.