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Senior Clinical Research Associate

Upsilon Global

Upsilon Global are seeking a freelance SCRA based in Lincoln to provide regionalised monitoring for two studies, estimated at 0.75 - 1.0 FTE. The studies are mainly early phase studies, we are seeking a SCRA with a strong background in early phase studies, demonstrating a strong scientific understanding of early phase studies as well as past monitoring experience. Key information: Position: Freelance SCRA Employment: 1099 contract FTE: 0.75 - 1.0 FTE Key Responsibilities: Conduct on-site visits, monitoring and assessment of clinical trial site, ensuring adherence to study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements. Perform source document verification, data collection, and accurate recording of study data, ensuring data integrity and compliance. Collaborate with site investigators, site staff, and study team members to ensure successful execution of clinical trials. Assist in the development and review of study documents, including protocols, informed consent forms, and case report forms. Maintain effective communication with study site, sponsors, and other stakeholders to provide timely updates, address queries, and resolve issues. Monitor subject safety, reporting adverse events, and ensuring appropriate follow-up actions are taken. Contribute to the preparation and coordination of study initiation, monitoring, and close-out activities. Assist in the preparation and participation in regulatory inspections and audits as necessary. Stay updated with current regulations, guidelines, and industry trends related to clinical research in translational/early-phase trials Experience: 5+ years independent monitoring experience A strong background in early-phase / phase I/II trials In-depth knowledge of U.S. regulatory requirements and clinical trial processes. Strong organizational and communication skills, with the ability to manage multiple priorities. Ability to work independently, demonstrating initiative, attention to detail, and problem-solving skills #J-18808-Ljbffr

Vacancy posted 3 days ago
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