Quality Associate II

Position Overview

We are seeking a Clinical Quality Associate to support quality and compliance activities across clinical research programs. This role will monitor study quality, assess risks, support inspections and audits, and partner with cross-functional teams to promote GCP compliance and continuous improvement.

Key Responsibilities

• Support quality oversight across clinical studies.
• Review quality metrics, compliance data, and study trends to identify risks and improvement opportunities.
• Evaluate protocol deviations, quality events, CAPAs, and compliance concerns.
• Support risk assessments, vendor oversight, and risk-based quality management activities.
• Review study documentation and quality records for compliance.
• Support audits, inspections, inspection readiness, and governance activities.
• Perform trend analysis and contribute to quality improvement initiatives.
• Collaborate with clinical and operational teams to support study execution and compliance.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Clinical Research, Public Health, Biostatistics, or a related scientific discipline.
• 4+ years of experience in Clinical Quality, Clinical Operations, Clinical Development, GCP compliance, or related clinical research functions.
• Experience supporting clinical trial quality and compliance activities.
• Experience with investigations, CAPAs, risk assessments, and quality reviews.
• Strong knowledge of ICH-GCP guidelines and clinical trial processes.
• Strong analytical, organizational, and communication skills.
• Ability to work independently and manage multiple priorities.

Preferred Qualifications

• Experience with risk-based quality management (RBQM) or risk-based monitoring (RBM).
• Experience supporting audits, inspections, vendor oversight, or inspection readiness activities.
• Experience with electronic quality management systems.
• Quality-related certifications (GCP, Lean Six Sigma, ASQ, RCA, or similar).
• Experience supporting global or multicenter clinical trials.

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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].