Manager, Research Compliance

Overview

The Research Compliance Manager serves as a member of the City of Hope Ethics and Compliance Department and is a leader within City of Hope’s research compliance program.  Reporting to the Executive Director of Ethics and Compliance, the Research Compliance Manager 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 Research Compliance Manager also is 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 Executive Director of Ethics and Compliance.  The Research Compliance Manager will also participate in and respond to various research– related audits.  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 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.    

Key Responsibilities include:

• Under the oversight of the Executive Director of Ethics and Compliance, conducts routine internal incident investigations and follow up including the development and monitoring of corrective actions.  Assists Executive Compliance Director with the conduct of research misconduct inquiries and investigations.    
• 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. 5% 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. 5% Supports the Corporate Compliance Office with performance of other compliance-related duties as requested.  

Basic education, experience and skills required for consideration:

• Bachelor’s degree.
• At least seven (7) years of experience in research compliance, preferably in a large academic medical center, or related experience in a similar field.  12 years of prior management experience.

Licensure/Certification preferred:

• Certified in Healthcare Research Compliance (CHRC)

Preferred education experience and skills:

• Master’s or other graduate degree (e.g., MPH, MBA, MHA, JD, MD, etc).

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.