Atrium Health - Charlotte, NC
posted 3 months ago
The Atrium Health Oncology Clinical Site Monitor II is a full-time position responsible for overseeing clinical trials to ensure compliance with protocols, Good Clinical Practice (GCP), and regulatory requirements. This role involves managing studies with minimal oversight, ensuring patient safety and well-being, and verifying the accuracy of clinical trial data. The Clinical Site Monitor will assist in the compilation of required documents for trial activation and will play a crucial role in training research staff. The position requires a proactive approach to analyzing supplies, procedures, and processes at medical sites, suggesting improvements as necessary. Additionally, the monitor will be responsible for monitoring informed consent and eligibility processes, ensuring that all aspects of the trials are conducted ethically and in accordance with established guidelines. The essential functions of this role include working independently and as part of a sponsor team, managing multiple complex trials, and performing site selection, interim, and close-out monitoring visits. The Clinical Site Monitor will review study drug storage, stability, inventory, and accountability, and will verify the destruction of unused products as required. Communication is key in this role, as findings must be reported in a timely manner to all sites according to the timelines defined in the LCI QA SOPs and guidelines. The monitor will also set up meetings to discuss concerns or findings with the site Principal Investigator (PI) or Sub-Investigator (SI). In addition to these responsibilities, the Clinical Site Monitor will develop Protocol Specific Monitoring Plans, collaborate with research sites to prepare for Co-operative Group audits and FDA inspections, and conduct training sessions on Quality Assurance and site expectations. Participation in protocol and electronic Case Report Form (eCRF) development, as well as the updating of LCI QA SOPs, guidelines, and processes, is also expected. This position primarily works in an office setting but may require mobility within the healthcare system and external locations involved in LCI clinical trials, some of which may be out of state.