Senior Clinical Research Associate

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

Location: Lincoln, Nebraska

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