Clin Trials QA Specialist

Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.

The Clinical Trial Quality Assurance Specialist will participate in activities for supporting Quality Assurance department to ensure compliance with GCP, institutional and regulatory standards. This includes support in audit programs, risk management plans, regulatory inspections, generating metrics for continuous improvement, and quality events while collaborating cross-functionally within System Clinical Trials to uphold clinical trial quality and regulatory compliance.

This position works collaboratively with investigators, research staff, pharmacy, and leadership to identify compliance gaps through active data analysis using system generated reports and dashboards, implement sustainable corrective actions to help maintain a state of readiness for regulatory inspections, sponsor audits, and other regulatory authority reviews.

As a successful candidate, you will:

• 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.

Your qualifications should include:

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.

City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.

To learn more about our Comprehensive Benefits, please CLICK HERE.