Clinical Research Associate (CRA) – Early Phase | Contract

Fidelis Companies; Lincoln (NE); Hybrid; USD 70,000 - 110,000; Full time

Job summary

Fidelis Companies in Lincoln, Nebraska is seeking an experienced Clinical Research Associate for a contract role with hybrid onsite travel to a single Lincoln site. You will conduct site initiation and monitoring visits, ensure protocol and regulatory compliance, and collaborate with site personnel and internal teams to maintain study progress.

Phase I or early-phase exposure is preferred, with strong knowledge of ICH-GCP and FDA regulations guiding your daily activities and risk management.

Qualifications

• Extensive CRA experience in CRO or sponsor settings.
• Strong knowledge of ICH-GCP and FDA regulations.
• Ability to travel to Lincoln, Nebraska for onsite monitoring.
• Phase I or early-phase experience preferred.

Responsibilities

• Conduct site initiation, interim monitoring, and closeout visits as needed.
• Monitor study conduct, protocol compliance, subject safety, and data quality.
• Perform source data review and source data verification.
• Review informed consent forms, regulatory documents, and essential study records.
• Identify and follow up on site issues, protocol deviations, and outstanding action items.
• Prepare monitoring reports and follow-up correspondence.
• Work closely with site personnel and internal clinical teams to keep studies on track.
• Provide site guidance and training on protocol and study requirements.
• Escalate compliance, quality, or study risks when appropriate.

Skills

CRA experience

Independent working

Strong communication

Monitoring experience

Job description

Clinical Research Associate (CRA) – Early Phase | Contract

Contract | Hybrid | Travel to Lincoln, Nebraska

We are working with a mid-sized CRO specializing in early-stage clinical trials that is looking to add an experienced Clinical Research Associate to its Clinical Operations team on a contract basis.

This role is a good fit for a CRA who is comfortable working independently, has strong monitoring experience, and enjoys the variety that comes with supporting different studies and therapeutic areas.

A unique aspect of this opportunity is the travel. Rather than covering a large regional territory, onsite travel is limited to one clinical research site in Lincoln, Nebraska.

Responsibilities

• Conduct site initiation, interim monitoring, and closeout visits as needed
• Monitor study conduct, protocol compliance, subject safety, and data quality
• Perform source data review and source data verification
• Review informed consent forms, regulatory documents, and essential study records
• Identify and follow up on site issues, protocol deviations, and outstanding action items
• Prepare monitoring reports and follow-up correspondence
• Work closely with site personnel and internal clinical teams to keep studies on track
• Provide site guidance and training on protocol and study requirements
• Escalate compliance, quality, or study risks when appropriate

Qualifications

• Extensive experience as a Clinical Research Associate within a CRO, sponsor, or similar clinical research environment
• Working knowledge of ICH-GCP, FDA regulations, and clinical trial requirements
• Strong understanding of source documentation, informed consent, protocol deviations, and regulatory documentation
• Ability to manage studies and site responsibilities independently
• Strong communication, organization, and documentation skills
• Ability to travel to Lincoln, Nebraska for onsite monitoring

Phase I or early-phase clinical trial experience is preferred but not required.

We are open to candidates from a variety of therapeutic-area backgrounds. The priority is finding an experienced CRA with strong monitoring fundamentals who can quickly learn new protocols and work effectively across different studies.

Why This Opportunity?

You’ll join a mid-sized CRO focused on early-stage research, giving you exposure to a diverse portfolio of clinical trials without the extensive multi-state travel typically associated with CRA positions.

If you're an experienced CRA looking for a contract role with early-phase exposure, study variety, and a more concentrated travel model, we'd like to hear from you.