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. 

Performs comprehensive quality control (QC) monitoring of source documentation for City of Hope clinical trials. Reviews internal regulatory documents, protocols, amendments, correspondence and serious adverse event reports to maintain current knowledge and requirements of relevant protocols.  Performs extensive QC visits to confirm appropriate source documentation in electronic health record (laboratory data, transfusion services records, and any other source used to produce study data) and in other electronic patient records (Florence eBinder) to confirm protocol compliance (including QC review of consent and eligibility criteria). Performs extensive review of case report forms and study data, utilizing medical records, laboratory data, transfusion services records, and any other source used to produce study data.  Generates QC report, summarizing the findings of all deviations, discrepancies, and incorrect or missing source documentation.  This role ensures the research enterprise maintains high standards of care and adheres to federal, state, and local regulations.

As a successful candidate, you will: 

• Ensures timely reporting of Serious Adverse Events (SAEs) to all required regulatory agencies and external sponsors.

• Reviews protocols and amendments to stay current with eligibility, treatment, and documentation requirements; develops study-specific QC and risk-assessment plans.

• Identifies clinical trial issues and quality risks, proposes and implements corrective actions, and presents quality, compliance, and risk-management reports to research leadership.

• Conducts QC monitoring, investigates protocol deviations and documentation discrepancies, generates monitor reports, and provides training to investigators, CRCs, nurses, and sponsors as needed.

• Serves as a subject matter expert on clinical research documentation and regulatory standards, contributes to enterprise QA initiatives, and may travel to participating sites for monitoring activities.

Your qualifications should include: 

• Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or a related scientific field.

• Minimum of three years of experience as a Clinical Research Associate or clinical trial monitor, specifically in Oncology and/or Hematology trials.

• Strong understanding of IND procedures, study protocols, informed consent processes, and applicable regulatory requirements.

• Knowledgeable in Good Clinical Practice (GCP) guidelines and other relevant clinical research standards.

• Must obtain certification as a Clinical Research Associate (ACRP) or Clinical Research Professional (SoCRA) within one year of hire.