Senior Clinical Research Associate

Upsilon Global; Lincoln (NE); On-site; USD 83,000 - 124,000; Part time

Job summary

Upsilon Global is seeking a freelance SCRA based in Lincoln, Nebraska to provide regionalised monitoring for two studies estimated at 0.75–1.0 FTE on a 1099 contract basis.

The ideal candidate will have 5+ years of independent monitoring experience, with a strong background in early-phase (I/II) trials and solid knowledge of U.S. regulatory requirements. Strong organizational skills and proactive problem-solving are essential.

Qualifications

• 5+ years independent monitoring experience.
• Strong background in early-phase / phase I/II trials.
• In-depth knowledge of U.S. regulatory requirements and clinical trial processes.
• Excellent organizational and communication skills.

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

Skills

SCRA monitoring

GCP knowledge

Data integrity

Regulatory knowledge

Site collaboration

Independent work

Job description

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