Clinical Quality Associate

3 weeks ago

Princeton NJ, United States GForce Life Sciences Full time

Clinical Quality Associate Have you got what it takes to succeed The following information should be read carefully by all candidates. 12-month contract Hybrid in Princeton, NJ - onsite on Wednesday Responsibilities: Shadow and support quality oversight activities for 10+ ongoing clinical studies (from planning to reporting stages), ensuring best practices are identified and followed. Partner and communicate with Clinical Managers (CMs) and Functional Area (FA) stakeholders to provide cross-functional team support and attend project/study-level meetings. With guidance from senior GCP auditors, consult on and escalate major/critical quality issues, serious breaches, data integrity concerns, and protocol deviations to senior management. Conduct periodic resolution checks and follow-ups on quality issues for assigned studies. Contribute to risk assessments and development of the annual GQM Audit Plan by recommending the number and type of site/vendor audits based on study risk. Gather and provide study-related documentation and insights to the audit team and GCP Level 2 auditors in preparation for audits. Participate in the risk evaluation of preferred and active vendors to support the annual GQM Vendor Audit Plan. Support CAPA (Corrective and Preventive Action) reviews stemming from quality issues, audits, inspections, and eTMF (electronic Trial Master File) assessments. Engage in weekly, monthly, and quarterly GQM GCP team meetings, as well as QA:QA and Quality Council meetings alongside senior audit team members. Assist in the review and harmonization of controlled documents including protocols, informed consent forms (ICFs), clinical study reports (CSRs), amendments, SOPs, and templates. Participate in ongoing GCP training, including ICH E6 R3 guidelines, 21 CFR modules, and team-led educational sessions. Provide support across portfolio-wide inspection readiness activities (sponsor, site, CRO), including delivery of Do & Dont training, interview preparation, debriefs, and findings analysis. Review and assess the Pharmacovigilance System Master File (PSMF) and conduct PV-related quality activities as assigned. Qualifications: Bachelors degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field. 12 years of experience in clinical research, clinical quality assurance, or GxP-related functions preferred. Familiarity with GCP guidelines (ICH E6) and FDA 21 CFR Part 11 and 312 regulations. Strong organizational and communication skills with the ability to work cross-functionally. Analytical mindset with the ability to identify and assess quality risks. Demonstrated ability to learn in a fast-paced, collaborative environment. Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Previous exposure to TMF systems, CAPA processes, or audit support is a plus. Interest in building a career in clinical quality, auditing, or compliance.

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