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DIRECTOR, QUALITY CONTROL AND QUALITY ASSURANCE - CLINICAL RESEARCH - 10028870
Anywhere, USACity of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases.
Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a wholly owned subsidiary, was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope’s exceptional cancer expertise.
A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.
Director, Quality Control and Quality Assurance - Clinical Research (Remote)
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.
Under the supervision of the Executive Director, System Clinical Research Quality Assurance Program, the Director of Clinical Research Quality Control and Quality Assurance leads the Quality Assurance and Quality Control team for the COH research enterprise. This role ensures clinical data quality, regulatory compliance, and integrity of research documentation while collaborating with key oversight committees and system leaders. The Director proactively manages compliance requirements, stays updated on regulatory guidelines, and implements effective administrative processes to maintain excellence in clinical trial management.
As a successful candidate, you will:
- Provide leadership and oversight to QA and QC teams, ensuring effective training and fostering educational growth.
- Retain and develop high-quality managers skilled in regulatory compliance, data quality, and documentation best practices.
- Collaborate with internal stakeholders to maintain strong relationships and support clinical teams in risk identification and mitigation.
- Ensure cutting-edge quality control processes align with industry best practices and Federal regulations, implementing continuous improvement initiatives.
- Design and maintain quality assurance monitoring plans, providing performance metrics and ensuring inspection readiness across clinical teams.
- Represent the organization at national conferences, and participate in regulatory site visits and audits, leading corrective actions when needed.
Your qualifications should include:
- Bachelor’s Health Care Administration, Clinical Research or related field.
- Seven years progressively responsible experience related to quality control/quality assurance, auditing, monitoring, or conduct of clinical trials.
- Minimum of five years of experience related to the management and conduct of oncology clinical trials in an academic setting required.
- Experience in coordinating and managing the efforts of personnel who work in the clinical trials arena.
- Working knowledge of policies and procedures that govern clinical research, including but not limited to FDA and DHHS regulations, Good Clinical Practices, Health Insurance Portability and Accountability Act (HIPAA), National Cancer Institute Cancer Center Support Grants (NCI CCSG) requirements and City of Hope Comprehensive Cancer Center programs and processes.
- Experience working with FDA investigations.
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, pleaseCLICK HERE.