Clinical Trials QA Specialist
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Job Description
Quality Assurance Specialist at City of Hope ensuring compliance with clinical trial regulations and quality assurance in clinical trials. Collaborating with various teams to maintain data integrity and regulatory readiness.
Responsibilities:
- Generate QA reports and quality metrics from clinical trial systems (e.g., OnCore, Medidata RAVE, CTSU, SpecTrak) to identify trends, discrepancies, and operational insights.
- Prepare clear reports for research leadership to evaluate staff adherence to SOPs, workflows, and regulatory requirements.
- Review clinical trial data to assess compliance with FDA regulations, ICH-GCP guidelines, sponsor requirements, and institutional policies.
- Identify and escalate quality issues, data gaps, compliance risks, and process inefficiencies while recommending corrective action plans.
- Collaborate with study teams and leadership to improve quality operations, support audit readiness, and enhance clinical trial oversight.
Requirements:
- Minimum Education: Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields.
- Minimum Experience: 2 years of related experience
- Familiar with Investigational New Drug procedures, study protocols, the informed consent process, Good Clinical Practices (GCPs), and applicable regulatory requirements.
- Be able to work with large datasets, perform data analysis, assess trends, discrepancies and present findings.
- Preferred Education: Master’s degree preferred.
- Preferred Experience: At least one year of experience in Clinical Research for Oncology and/or Hematology clinical trials.
Benefits:
- Comprehensive Benefits
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