Clinical Research Associate (CRA) - Early Phase | Contract Job at Fidelis Companies, Lincoln, NE

  • Fidelis Companies
  • Lincoln, NE

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
  • 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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Job Tags

Contract work, Interim role

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