Clinical Trial Quality Control Monitor

Clinical Trial Quality Control Monitor

Join the transformative team atCity 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.

This role performs detailed quality control (QC) reviews of clinical trial documentation for City of Hope studies. Responsibilities include reviewing protocols, regulatory documents, and adverse event reports; conducting extensive QC checks of source data in electronic health records and patient files to ensure protocol compliance; and verifying data accuracy across various sources. The position also generates comprehensive QC reports highlighting any discrepancies or documentation issues, helping ensure the organization meets regulatory standards and maintains high-quality research practices.

As a successful candidate, you will:

• Review protocols, amendments, and regulatory documentation to ensure compliance with current study requirements and adequate source documentation.
• Verify timely reporting of Serious Adverse Events (SAEs) to regulatory agencies and sponsors.
• Create and implement study-specific QC review and risk assessment plans to ensure data accuracy and consistency.
• Identify and resolve clinical trial quality issues, recommend corrective actions, and present findings to research leadership.
• Generate QC reports summarizing protocol deviations and documentation discrepancies; investigate and correct incomplete or inaccurate records.
• Serve as a subject matter expert on clinical research documentation and QA processes, contributing to enterprise-wide initiatives and improvements.

Your qualifications should include:

• Bachelor's degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields.
• Three or more years of experience as Clinical Research Associate or clinical trial monitor for Oncology and/or Hematology clinical trials.
• Familiar with Investigational New Drug procedures, study protocols, the informed consent process, Good Clinical Practices (GCPs), and applicable regulatory requirements.
• Trained and certified as a Clinical Research Associate by the Association of Clinical Research Professionals (ACRP) or as a Clinical Research Professional by the Society of Clinical Research Associates (SoCRA) within one year of hire.

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 Comprehensive Benefits, please CLICK HERE.