Full-time
FSP Clinical Research Associate
Competitive
Mid, Senior LevelScience & PharmaceuticalPosted 21d ago
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Role overview
Job type
Salary
Competitive
Location
Sector
Posted
21 days ago
Job description
ClinLab Solutions Group is hiring a field-based FSP Clinical Research Associate to monitor clinical trial sites from qualification through close-out. The role ensures protocol compliance, data quality, subject safety, site performance, and audit-ready documentation, with heightened vigilance for CNS and psychiatry trials.
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
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
CNS Monitoring
Psychiatry Monitoring
Depression Monitoring
MADRS Familiarity
C-SSRS Familiarity
Central-Rater Workflows
Risk-Based Monitoring
Short-Duration Study Designs
Open-Label Study Designs
Company
Life sciences staffing and resourcing from discovery to commercialization.
Watertown, Massachusetts, USA
https://clinlabstaffing.com/
Founded in 2002
201-500 employees
Qualifications
US: 2+ years independent on-site monitoring (Sr/Lead: 4+ years, incl. mentoring or lead-CRA duties)
strong SDV and documentation discipline
Bachelor's in a life-science or related field
Strong SDV and documentation discipline
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
US: 2+ years independent on-site monitoring (Sr/Lead: 4+ years, incl. mentoring or lead-CRA duties).
Required skills
Clinical Trial Monitoring, Source Data Verification, CNS/Psychiatry Clinical Research, MADRS, C-SSRS, Central-Rater Workflows, Risk-Based Monitoring, Open-Label Clinical Trials
Preferred skills
Watertown, Massachusetts, USA, https://clinlabstaffing.com/, Growth Stage, Leadership Team, Adam Katz, EVP of People & Development, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness
Experience
2+ years
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