Clinical Quality Assurance Associate II

GForce Life Sciences; Princeton (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

GForce Life Sciences seeks a Quality Associate II to support quality oversight across multiple clinical studies from protocol development through closeout and reporting.

The role involves reviewing quality metrics, identifying risks, and collaborating with cross-functional teams to ensure quality is integrated into study design, risk management, and execution plans. Requires 4+ years in clinical trials and strong knowledge of ICH-GCP and FDA/EMA regulations.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, Biostatistics, Clinical Research, or related field.
• Minimum of 4 years supporting clinical trials in pharma, biotech, medical device, or CRO.
• Experience with clinical trial design, oversight, and reporting across development phases.
• Ability to analyze clinical and operational data to identify trends and quality improvements.
• Strong knowledge of ICH-GCP, FDA, EMA, and global regulations.
• Experience conducting quality reviews, CAPA assessments, and risk evaluations.
• Excellent written and verbal communication with strong organization.

Responsibilities

• Provide quality oversight for clinical studies across protocol development to closeout.
• Identify risks, compliance issues, and opportunities for process improvements.
• Collaborate with cross-functional stakeholders to integrate quality into study design and execution.
• Evaluate protocol deviations, data integrity issues, and non-compliance events.
• Follow-up on CAPAs, audit findings, and inspection observations.
• Support risk assessments and quality management for vendors in studies.
• Review quality documentation including protocols, consent forms, amendments, CSR, and records.
• Perform trend analysis of quality metrics to identify systemic issues and mitigation strategies.
• Support inspection readiness across Sponsor, CRO, and investigational sites.
• Participate in audit planning, prioritization, and governance forums.
• Mentor junior quality professionals and assist with onboarding.

Skills

Data analysis

Communication

Independent judgment

Quality oversight

Education

Bachelor’s degree in Life Sciences or related

Tools

Microsoft Office

TrackWise

Data analysis tools

Job description

GForce Life Sciences seeks a Quality Associate II to support quality oversight across multiple clinical studies from protocol development through closeout and reporting.

The role involves reviewing quality metrics, identifying risks, and collaborating with cross-functional teams to ensure quality is integrated into study design, risk management, and execution plans. Requires 4+ years in clinical trials and strong knowledge of ICH-GCP and FDA/EMA regulations.