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 Manager, Research Compliance serves as a member of the City of Hope Ethics and Compliance Department and is a part of City of Hope’s research compliance program. Reporting to the System Director, Research Compliance, the Manager, Research Compliance provides critical regulatory oversight of City of Hope’s clinical and basic science research programs, and assists with designing, implementing, and maintaining research standards of conduct in accordance with all applicable laws, regulations, and best practices. The Manager is also responsible for responding to research compliance-related inquiries including investigations, corrective action plans, monitoring, and improvement activities, and using judgment and expert knowledge to escalate issues to the System Director, Research Compliance. The Manager manages the regulatory and clinical trial auditing function, and supports the System Director, Research Compliance, in managing the day-to-day operations of the Research Compliance Program. The Research Compliance Manager keeps open lines of communication with other departments including the Office of Sponsored Research, Clinical Trials Office, Clinical Trial Support Services, Office of Human Research Subjects Protection, Laboratory Research Protections, Office of Technology Transfer, Office of General Counsel and also with various levels of staff regarding research issues. Individual must possess excellent judgment, attention to detail, strong writing and verbal communications skills, and be able to make critical decisions based on data analysis and a strong understanding of the legal and regulatory requirements applicable to clinical and basic science research.

As a successful candidate, you will:

• Manages and administers the regulatory and clinical trials auditing programs and conducts internal incident investigations including development and monitoring of corrective actions. Assists System Director with the conduct of research misconduct inquiries and investigations.
• Manages and administers the research compliance education and outreach efforts of the Research Compliance Program. Serves as a department liaison with other departments to facilitate research compliance training and outreach activities and coordinate outreach efforts and obtain COH workforce feedback on outreach activities.
• Acts as a resource for research compliance and research billing-related inquiries, including receipt, evaluation and follow up. Gathers information and data needed to make decisions and provide expert advice.
• Leads compliance committees and provides expert advice to research regulatory committees, as needed, and leads special projects relating to the area of expertise as requested. Leads projects involving data management using database tools.
• Develops and maintains departmental policies and procedures.
• Maintains current knowledge of the application of federal and state laws, regulations and policies relevant to area of expertise such as, the Health Insurance Portability and Accountability Act (HIPAA), the Medicare Clinical Trial Policy, the Federal Policy for the Protection of Human Subjects (the Common Rule), the FDA regulations for the conduct of human subject research (Title 21 CFR), the PHS Policies on Research Misconduct, the PHS Policy on Humane Care and Use of Laboratory Animals and enhances professional growth and development by participating in educational programs relating to such topics.

Your qualifications should include:

• Bachelor’s degree
• At least eight (8) years of experience in research compliance, preferably in a large academic medical center, or related experience in a similar field.
• Master’s or other graduate degree (e.g., MPH, MBA, MHA, JD, MD, etc), preferred.
• Certified in Healthcare Research Compliance (CHRC) preferred.

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

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