Clinical Research QA Specialist

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 13%

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Saratoga Ascend

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1985

🏥 Healthcare

🎯 Recruiter

🏛️ Government

Healthcare • Recruitment • Government

Saratoga Ascend is a federal- and state-focused healthcare workforce and solutions firm that connects cleared, credentialed healthcare professionals with government, military, and civilian healthcare facilities across the U. S. The company provides clinical and non-clinical staffing, clinical lab and scientific staffing, call center services, federal healthcare consulting, IT solutions, program and administrative support, and SLED (state, local, education) services. With a stated four-decade legacy, nationwide coverage, rapid-fill capabilities, strict credentialing/compliance processes, and operation under federal contract vehicles, Saratoga Ascend positions itself as a government-focused healthcare staffing and program management partner.

📋 Description

• Develop and maintain monitoring SOPs and quality management documents • Conduct quality review of monitoring reports, essential documents and regulatory files • Track and verify CAPA and the effectiveness of corrective actions • Conduct or support internal audits and inspection readiness activities • Deliver GCP and protocol training for clinical research staff

🎯 Requirements

• Bachelor's degree in a life science or related field • QA certification (e.g., CQA, RQAP-GCP) preferred • Minimum of 5 years of quality assurance or clinical research experience • At least 3 years in GCP quality functions for NIH- or FDA-regulated studies • Strong analytical, documentation and communication skills • Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs • Working knowledge of Good Clinical Practice (ICH E6) • Working knowledge of 21 CFR Parts 11, 50, 54, 56, 312 and 812, as applicable • Working knowledge of 45 CFR Part 46 and HIPAA • Current human subjects protections and GCP training (e.g., CITI or equivalent) • Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials

🏖️ Benefits

• Competitive rate • Benefit options • Equal opportunity employment

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