Clinical Research Associate (CRA) - Early Phase | Contract
Fidelis Companies
Job Description
Clinical Research Associate (CRA) – Early Phase | Contract
\nContract | Hybrid | Travel to Lincoln, Nebraska
\nWe 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.
\nThis 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.
\nA 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.
\nResponsibilities
\n- \n
- Conduct site initiation, interim monitoring, and closeout visits as needed \n
- Monitor study conduct, protocol compliance, subject safety, and data quality \n
- Perform source data review and source data verification \n
- Review informed consent forms, regulatory documents, and essential study records \n
- Identify and follow up on site issues, protocol deviations, and outstanding action items \n
- Prepare monitoring reports and follow-up correspondence \n
- Work closely with site personnel and internal clinical teams to keep studies on track \n
- Provide site guidance and training on protocol and study requirements \n
- Escalate compliance, quality, or study risks when appropriate \n
Qualifications
\n- \n
- Extensive experience as a Clinical Research Associate within a CRO, sponsor, or similar clinical research environment \n
- Strong independent site-monitoring experience \n
- Experience conducting onsite monitoring visits \n
- Working knowledge of ICH-GCP, FDA regulations, and clinical trial requirements \n
- Strong understanding of source documentation, informed consent, protocol deviations, and regulatory documentation \n
- Ability to manage studies and site responsibilities independently \n
- Strong communication, organization, and documentation skills \n
- Ability to travel to Lincoln, Nebraska for onsite monitoring \n
Phase I or early-phase clinical trial experience is preferred but not required.
\nWe 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.
\nWhy This Opportunity?
\nYou'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.
\nIf 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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