Quality Associate II

About the role

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.

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.

Requirements

• 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.

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.

Benefits

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