Early-Phase CRA – Hybrid Contract (Lincoln, NE)

Fidelis Companies

Lincoln (NE)

Hybrid

USD 70,000 - 110,000

Full time

6 days ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

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.