FSP Clinical Research Associate
Company: ClinLab Solutions Group Agency
- Location: United States
- Seniority: Mid level
- Employment type: Full-time
- Posted: 14 days ago
- Offer language: English
Job description
CLINICAL RESEARCH ASSOCIATE (CRA), FIELD-BASED
KEY RESPONSIBILITIES
- Conduct site qualification, initiation, interim monitoring, and close-out visits per the monitoring plan.
- Perform source data verification and review; ensure protocol compliance, data quality, and subject safety.
- Manage strong site relationships; drive enrollment and timely query resolution in short-duration studies.
- Oversee investigational product accountability and essential-document/TMF currency at the site.
- Apply heightened data-integrity and enrollment-fraud vigilance appropriate to CNS/psychiatry trials.
- Escalate risks and findings promptly; keep visit reports and trackers audit-ready.
REQUIRED QUALIFICATIONS
- US: 2+ years independent on-site monitoring (Sr/Lead: 4+ years, incl. mentoring or lead-CRA duties).
- Willingness to travel to sites per the monitoring plan; strong SDV and documentation discipline.
- Bachelor’s in a life-science or related field.
PREFERRED
- CNS / psychiatry / depression monitoring experience; familiarity with MADRS, C-SSRS, and central-rater workflows.
- Risk-based monitoring experience; comfort with short (<12-week) and open-label designs.
