Director of Clinical Compliance
The Director of Clinical Compliance assists in the development of clinical compliance program activities to identify potential compliance risks in clinical services lines including human subject research. This position provides support for compliance policies and procedure development and implementation, develops and implements auditing and monitoring activities to identify potential risks, develops training and education resources, conducts compliance investigations, and prepares compliance reports. The Director of Clinical Compliance has significant interaction with Quality and Clinical Services, Patient Financial Services, Health Information Management, Ancillary Services, Legal, Internal Audit, and other departments.
Essential Duties and Responsibilities:
â€¢Ensure full implementation of the CHS Corporate Compliance Program in clinical areas of affiliated entities such as Human Subject Research programs, Behavioral Health entities, Ambulance providers, among others.
â€¢Develop training and education programs for regulatory changes and topics identified as potential risk areas.
â€¢Structure tools for use with compiling data and trend analysis.
â€¢Collect and analyze original data source documents, including computer A/P files, for various compliance audits (e.g., research activities)
â€¢Assess auditing and monitoring trends and coordinate mitigation activities when opportunities for improvement (audit variances) are identified.
â€¢Prepare oral and written reports, including recommendations for improvement based on audit and investigative findings.
â€¢Serves as a liaison with contracted research operations team to ensure hospital research activities are monitored to identity potential risk areas. Assists in the development of corrective action plans related to research program activities.
â€¢Maintain an awareness of current laws, statutes, regulations, etc. that impact healthcareclinical operations.
â€¢Conduct focused compliance audits on topics of concern.
â€¢Coordinate compliance policy development and/or revision, when necessary.
â€¢Participate in compliance and privacy investigations.
â€¢Other duties as assigned by the VP, Corporate Compliance and Privacy Officer.
Education and Experience:
Bachelorâ€™s degree in Health Information Management, Nursing, Business, or related area, or three or more yearsâ€™ experience in compliance functions.
A minimum of three (3) yearsâ€™ experience in the conduct of clinical research is required; specifically working with federal regulations related to human subjects protection.
A minimum of two (2) years of IRB management experiencepreferred.
A minimum of two (2) yearsâ€™ experience in HIPAA compliance, research compliance and/or health care compliance preferred.
Experience overseeing account auditing activities to assure each participant enrolled in a clinical research protocol is correctly identified and registered for protocol goods and services for accurate billing to sponsors and third party payors;
Serves as a resource and/or liaison to affiliates conducting research activities or projects under the guidance of centralized IRB and research operation support staff;
Collaborates with corporate research operations staff to oversee clinical research billing activities to ensure the completion of Coverage Analysis (CA) and provides guidance for the adherence to the rules and regulation over the proper operation of the Institutional Review Boards.
The Director must have the ability to plan, develop, and present educational or programmatic materials in front of an audience greater than 20 people.
English is required for both spoken and written communication.
Candidate must be able to sit for long periods of time. Candidate must have the ability to lift carry-on-luggage overhead.
Corporate office environment, some travelrequired.