Research Compliance Program Manager

At Children’s Wisconsin, we believe kids deserve the best.

Children’s Wisconsin is a nationally recognized health system dedicated solely to the health and well-being of children. We provide primary care, specialty care, urgent care, emergency care, community health services, foster and adoption services, child and family counseling, child advocacy services and family resource centers. Our reputation draws patients and families from around the country.

We offer a wide variety of rewarding career opportunities and are seeking individuals dedicated to helping us achieve our vision of the healthiest kids in the country. If you want to work for an organization that makes a difference for children and families, and encourages you to be at your best every day, please apply today.

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Position is responsible for the review of applicable existing and new laws and regulations regarding human subject research for inclusion in the enterprise risk management process and in the compliance plan; timely review of research protocols for required compliance elements; the design and execution of auditing and monitoring processes; providing education on compliance risks regarding human subject research; review of billing for research protocols; collection and analysis of data; identifying control or compliance issues; presenting conclusions to management orally or in written reports; assisting management in the development of practical methods for improvement; and providing education on research compliance issues to researchers throughout the campus and to management.

ESSENTIAL FUNCTIONS:

• Exhibits guiding behaviors that reflect Children’s values and support our mission and vision.
• Monitors new and revised laws and regulations from the NIH, FDA, OHRP, OCR, OIG and any other governmental agency to ensure any risk areas are included in the overall CW enterprise risk management program and in the compliance plan, where applicable.
• Ensures CW has the appropriate research policies and procedures in place through the comparison of laws and regulations to existing policies and procedures. Facilitates the development and implementation of new or revised policies or procedures where necessary.
• Reviews research protocols for compliance with requirements to include conflict of interest, privacy and use or disclosure of protected health information, participant consent, data collection and retention, data sharing and data use agreements where applicable. Communicates with research coordinators to ensure necessary information is provided, and responds to questions and inquiries.
• Reviews and evaluates billing plans and budgets; ensures that services related to research studies are separated from the standard of care and research-related services are not billed to payers.
• Identifies research compliance education needs by researchers and management from CW, and leads educational efforts to disseminate information regarding current and revised laws and regulations and policies and procedures pertaining to human subject research and/or billing issues.
• Develops process improvements to ensure compliance with applicable laws and regulations including the billing for services provided to research participants per regulatory requirements.
• Designs and executes audit plans to identify if the processes are designed and operate effectively to ensure compliance with laws and regulations and policies and procedures regarding human subject research, including privacy and obtaining payment for research activities and patient care.
• Leads or conducts all investigations of activities alleged or suspected to violate federal and state research laws and regulations.
• Conducts interviews and examines a variety of operating records, research protocols and procedures, coverage analyses, use and disclosure of protected health information regarding human subject research and billing for research activities and patient care provided to research participants.
• Meets with management to discuss conclusions of auditing and monitoring activities and assists management with the design and implementation of process improvements; prepares and distributes written reports.
• Conducts reviews and presents conclusions of special projects as requested.
• Works closely with personnel from the CW Legal Department, Vice President Research Administration and team, and Medical College of Wisconsin research and compliance offices to ensure processes are in place to address, manage and resolve research issues.
  
  

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

• Bachelor’s degree required. Healthcare related field preferred.
• Seven years of clinical research or health care consulting experience.
• Specialized knowledge of clinical research protocols, practices and human subject protection regulations.
• Analytical and problem-solving skills to ensure that laws and regulations and policies and procedures are being followed consistently in order to ensure and promote adherence to the prescribed laws and regulations and policies and procedures, resulting in recommendations that add value for process improvements.
• Ability to research, collect, analyze and evaluate information relating to compliance with applicable human subject protection, privacy and healthcare billing.
• Excellent organizational and communication skills with ability to work with all levels of an organization.
• Requires the ability to plan and control assignments and to act independently without specific instruction with the scope of assigned responsibilities.
• Knowledge of computers applications to produce reports.
• Professional certification in research compliance preferred.
  
  

Children's Wisconsin is an equal opportunity / affirmative action employer. We are committed to creating a diverse and inclusive environment for all employees. We treat everyone with dignity, respect, and fairness. We do not discriminate against any person on the basis of race, color, religion, sex, gender, gender identity and/or expression, sexual orientation, national origin, age, disability, veteran status, or any other status or condition protected by the law.

Certifications/Licenses: