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Clinical Research Monitor
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$55,200 - $96,600 a year depends on experience
Full-time
- Job Req ID: 112971 Clinical Research Monitor The Department of Neurology is seeking a who will take the lead on compliance monitoring of predominantly large, multi-centered, clinical trials in keeping with established BIOS Clinical Trials Coordinating Center (CTCC) policies and procedures and GCP. The CRM will ensure quality, accuracy and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials through utilization of a risk-based, remote monitoring approach.
- In collaboration with clinical trial teams across the country, will support the clinical trial research goals of the CTCC by monitoring numerous centers specified trial cycle metrics and protocol fidelity, and oversee local, institutional and federally-required regulatory compliance across the network of collaborators.
- Ensure the collection and maintenance of required essential documents and ensure these documents are delivered to the Trial Master File. Assist in training new research staff regarding research compliance, including presentations sessions.
- Determine whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the Ethic Committees (IRB/IEC), Sponsor and the applicable regulatory requirement(s).
- Educate principal investigators, clinical sites and/or individual coordinators regarding remote monitoring and remote data entry through presentations.
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