Clinical Site Manager - Cancer Center

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13681697 Clinical Site Manager - Cancer Center Department: SOM KC Cancer Center Administration ----- KMCRI-Administration Position Title: Clinical Site Manager - Cancer Center Job Family Group: Professional Staff Job Description Summary: The Clinical Site Manager (CSM) oversees all aspects of clinical trial site monitoring, including routine monitoring visits, site close-out activities, and the maintenance of essential study documentation such as case report forms (CRFs) and regulatory files. This role is responsible for conducting pre-study and site initiation visits, serving as a liaison with external funders and sponsors, and performing additional duties as assigned. The CSM ensures the integrity, accuracy, and quality of clinical research activities by verifying that all studies are conducted in compliance with Good Clinical Practice (GCP) guidelines, applicable federal and sponsor regulations, KUCC policies and procedures, and approved clinical research protocols. The University of Kansas Cancer Center is the only National Cancer Institute designated Comprehensive Cancer Center in the region, 1 of only 57 in the nation to receive this distinction. Patients gain access to the most promising therapies, cutting-edge clinical trials and world class research. Job Description: Job Duties - Conduct interim monitoring review for all investigator-initiated trials developed by KUCC and managed by the Clinical Trials Office. This includes remote, risk-based monitoring (RBM) or source data verification (SDV) monitoring. - Ensure the protection of clinical trial participants by reviewing and verifying the informed consent process, subject eligibility and enrollment procedures, investigational product accountability, regulatory and Trial Master File documentation, and correlative laboratory collection and shipment records. - Oversee clinical trial data collection to confirm alignment with protocol-specific timepoints and requirements and maintain compliance with all applicable regulatory and institutional standards. - Confirm the validity and integrity of trial specific data submitted on Case Report Forms (CRFs) or other data collection tools by performing thorough and detailed source document review. Review data for missing or inaccurate data. - Generate detailed and concise monitoring visit reports, close-out visit reports and other documentation needed for Clinical Program Management to resolve outstanding protocol specific or institutional issues and queries. - Confirm clinical program management staff have received proper materials and instructions to enter sensitive health information and data points into CRIS/Velos CTMS. - Manage Investigator Initiated Trials (IIT) enrollment and registration process including randomization of study participants across all sites, providing timely study updates to all applicable site personnel. - Work with Site Development, IIT Regulatory, KUCC Finance and CTO Research Project Director on multisite IIT development, onboarding, and site initiation. - Act as a primary point of contact for academic institutions participating in multisite IIT. Develop and facilitate study start up materials and training for multisite IITs. - Support external audit and FDA inspection readiness, as requested, by conducting comprehensive reviews of essential study-specific documentation. Participate in KUCC Quality Assurance audits, inspections, and ad hoc review activities. - Provide ongoing training, mentoring, and coaching, while ensuring adherence to organizational policies a d procedures, as directed by the QA Project Manager or Senior Director of Quality Assurance. - Act as a Quality Assurance resource to clients of the Clinical Trials Office, evaluate problems and provide solutions. - Identify project issues and suggest possible solutions; manage problem resolution through expedient and corrective means. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice. Work Environment Travel as required to conduct interim monitor visits at multi-site IITs and attend national meetings. Off-site travel is limited but could be 5% 20%. Required Qualifications Work Experience: 6 years of relevant work experience. Relevant education may substitute for experience on a year for year basis. Experience with Clinic Coordination and/or On-site/Remote Monitoring and Risk-based or Source Data Verification Monitoring. Experience with FDA regulations relevant to drugs, devices, biologics.