Clinical Research Associate (CRA) - Early Phase | Contract
Fidelis Companies
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
- Strong independent site-monitoring experience
- Experience conducting onsite monitoring visits
- 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.
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