Clinical Research Associate (CRA) – Early Phase | Contract

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.has context menu