MCA Clinical Trials Director
The University of Kansas Cancer Center is seeking a Clinical Trials Director to be provide administrative oversite of The University of Kansas Cancer Center - Masonic Cancer Alliance (KUCC-MCA) Rural NCI Community Oncology Research Program (NCORP). Individual will assure billing and deliverables are complete and timely. Will be responsible for planning, training and oversight of the clinical trial programs at MCA member sites. Will also coordinate MCA sites' involvement in KUCC-MCA Rural NCORP, pharma sponsored and investigator initiated clinical trials.
· Responsible for the execution and oversight of MCA clinical trial operations and clinical research coordinator conduct at all MCA sites. Support activities involved to asure quality clincal research, including study initiation, investigator selection, preparing the site for study participation, and providing site specific education and training.
· Provide administrative oversite of the KUCC-MCA Rural NCORP. Leads NCORP reporting requirements. Works with KUCC-MCA PI's to assure that KUCC-MCA meets the accrual goals of the NCORP. Assures billing and deliverables are complete and timely. Facilitates contracting and invoicing for MCA sites.
· Identifies critical investigator organization selection criteria and assists with investigator training in collaboration with the MCA Medical Director. Design/support activities to assure quality clincal research, study initiation, preparing workflow for study participation, GCP understanding, clinical trial subject protection, consenting and privacy. Coordinate training new site staff and maintain education of existing staff. Provides CRA/pharmacy site specific training.
· Conduct monitoring visits for a certain percentage of data and source documentation. Assesses the collection and evaluation of research data for completeness, compliance, and accuracy. Advise timely and adequate documentation of study visits while adhering to the specific protocol requirements as well as International Center on Harmonisation and Good Clinical Practice guidelines and the most recent code of Federal Regulations.
· Provide guidance on reporting and follow-up correspondence. Prepare reports to KU human subjects committee when sites deviate from written protocol time lines or procedures. Collaborate with sites for analysis of errors and plan for correction. Follow-up with site to address KU delinquency and QA reports. Collaborate with CTO regulatory team.
· Consult with site coordinators regarding study drug ordering and storage. Create and maintain relationships with pharmaceutical companies for drug ordering.
· Collaborate with MCA site research staff to determine eligibility of screening patients based on specific protocol requirements, review eligibility, provide feed back, communicate to site if inclusion/exclusion criteria are or are not met. Oversee MCA site closeout visits; site follow-up, and final documents for closure.
· Inform MCA sites on how to prepare for FDA inspections, National Clinical Trials Network (NCTN) group audits and pharma monitoring. Manage preparation and completion of NCTN audits. Assures sites are prepared for inspections, audits, and monitoring.
· Supervises MCA clinical trial staff employed by KU Cancer Center.
Bachelor's degree in health or related field. Minimum 5 years experience in combined clinical research and oncology experience. Experience working with clinical research sites and staff. Knowledge of FDA regulations/GCP-ICH guidelines. SOCRA or ACRP certification. Detail oriented. Excellent interpersonal, verbal, and written skills. Preferred Qualifications:
RN preferred. Clinical trials monitoring experience in oncology. Clinical or public health experience. Prior experience managing enrollments, eligibility, scheduling, and treatment plans for subjects on oncology clinical trials.
KU Medical Center and the University of Kansas Cancer Center are Equal Opportunity/Affirmative Action employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disability status, or genetic information.