University of Florida Health Cancer Center
This position is located in the University of Florida Health Cancer Center Clinical Trials Office (CTO). The QA Manager (Manager, Clinical Research) assists the CTO Associate Director with quality assurance inspections and training of faculty and employees affiliated with the CTO. The incumbent will verify the accuracy of data; verify investigator compliance with the protocol and regulatory requirements; assess educational needs and instruct staff on good clinical practices related to patient management, data quality and data management; develop and implement policies and procedures; and develop and maintain a manual of procedures.
• Responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board policies and procedures and other regulations regarding human subject research and for directing and administering programs within the CTO which maintain institutional compliance with these regulations.
Quality Assurance and Monitoring Oversight:
• Directs and/or conducts internal and external inspections and audits of Institutional Review Board documentation and correspondence to ensure protocols, informed consents, addenda and safety reports have been submitted and approved in accordance with regulatory requirements, timelines and Standard Operating Procedures.
• Directs and/or conducts internal and external inspections and audits of subject medical records to ensure compliance with all project protocols; verifies source documentation and the accuracy of information entered on case report forms or into electronic databases. For each protocol, confirms that all eligibility criteria, stratification factors and required assessments are confirmed and each subject meets all eligibility criteria as specified in the protocol. Confirms that medical interventions were conducted according to the protocol, study treatment was administered according to the protocol, disease outcome (if applicable) was evaluated according to the protocol and all adverse events were assessed, correctly graded and reported according to the protocol.
• Directs and/or conducts internal inspections and audits of billing compliance documentation and correspondence to ensure that all study related procedures were billed according to the approved study billing plan and Medicare guidelines.
• Reviews Investigational Drug Service Department(s) to ensure proper drug accountability and storage procedures.
• Provides feedback and replies to PRMC and DSMB findings as it pertains to protocol development and data safety and monitoring, in particular for IIT’s.
• Prepares inspection and audit reports identifying deficiencies and makes general recommendations to improve performance.
• Assists with oversight of the University of Florida’s NCTN Cooperative Group memberships (CTSU, NRG, ECOG). Ensures that all local, affiliate and satellite sites of UF are in compliance with all cooperative group policies and procedures.
• Establishes and manages a written system of standard operating policies, procedures and guidelines for the conduct of research that are in alignment with those of sponsoring organizations, external regulatory agencies and central research administration offices.
• Serves as a regulatory liaison with institutional, local, state and federal external agencies, communicating directly with agency personnel as necessary.
• Coordinates all external regulatory and quality audits and inspections, outside of routine monitoring visits, identifying and resolving compliance issues and concerns, developing and implementing quality improvement plans to mitigate future risk and reporting on research compliance activities.
• Participates in the evaluation of research industry best practices for research compliance and quality assurance to develop metrics that drive improvement. Serves as research team liaison, providing communication and consultation services as needed. Maintains records, files and data for research regulatory and quality assurance efforts.
• Responsible for overall management of related center or group meetings, as well as meetings of applicable scientific advisory councils.
• Serves as a liaison between the CTO and its partnering sites, and other agencies and departments. Maintains regular contact and exchange of information with partners and other external entities in order to fulfill the clinical and research obligations of the CTO. Develops and maintains other relationships as warranted to benefit the CTO. Serves on taskforces for special projects for the CTO.
• Implements continuous process improvement across all trial types. Process improvement initiatives can be related to but are not limited to: trial implementation flow, timing of trial implementation, coordination of staff tasking and workload analysis, streamlined project assignment and delegation procedures, creation of staff accountability and performance evaluation through process improvement. Results of process improvement should be well documented and disseminated to CTO staff and vested institutional stakeholders through standard operating procedures.
• Master’s degree in appropriate area of specialization; or a bachelor’s degree in appropriate areas of specialization and two years of experience.
• Prior Oncology clinical trials experience and working knowledge of NCTN cooperative group system.
• Experience with monitoring and/or auditing.
• Research certification (ACRP/SOCRA)
• Experience with Excel, PowerPoint and Word.
• Must work independently, interact professionally, interpret complex policies and procedures and possess effective technical writing and organizational skills.
• Licensure as a Registered Nurse in the state of Florida
Please submit an application along with cover letter, C.V./resume, and reference list at: explore.jobs.ufl.edu