Clinical Quality Associate

Clinical Quality Associate

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 & Don’t 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:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field.
• 1–2 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.