Director of Research Compliance

Overview

Job Summary

The Research Compliance Director is a leader in the Enterprise Compliance Office and will be responsible for the development and implementation of compliance activities that helps to ensure the Enterprise research program complies with all appropriate rules and regulations regarding the conduct of human and animal research. Specific research compliance activities cover a wide range of topics such as: clinical research billing; grant financial management; conflicts of interest in research; international research compliance; export control; intellectual property management; research data and privacy; protection of human subjects in research; animal care and use programs; and research misconduct.

The Director will be independent of the Office of Research / CTSI, but will have a close working relationship with the Assistant Dean of Regulatory Affairs & Research Integrity, Director of Clinical Research, Director of Sponsored Programs, and other members of the Office of Research / CTSI.  This position, working with the senior leaders in the Enterprise Compliance Office, will direct the daily efforts of the Enterprise Compliance Office to maintain and communicate general compliance policies and standards to faculty and other research teammates and provide regulatory oversight and monitoring.

The Research Compliance Director will work closely with the Chief Privacy and Compliance Officer, Deputy Chief Compliance Officer and other leaders in the Enterprise Compliance Office to design, implement, maintain, and enforce the Enterprise-wide Compliance Plan.  This position will participate in the development of the annual compliance work plan and the continual evaluation and assessment of the System’s risks, concentrating on compliance issues related to research activities.  Through this risk assessment, this position will help identify research compliance issues, design auditing / monitoring processes to evaluate the issues, and communicate the results to senior leadership, faculty, and teammates.  This position is responsible for ensuring that all research projects identified on the annual compliance work plan are managed within budgeted timelines and priorities are appropriately adjusted for unplanned reviews.

This position will serve as the primary Enterprise Compliance Office contact for questions or concerns relating to research and will be responsible for ensuring that these concerns and issues are directed and / or reported to the appropriate Enterprise personnel for investigation and resolution.  This position will coordinate identified compliance issues with the Legal Department, when appropriate.

Work is across all markets and occasional travel primarily between Charlotte, NC and Winston-Salem, NC may be necessary.  The position may be based in Charlotte, NC or Winston-Salem, NC.

Essential Functions

• Developing and accessing Enterprise policies, procedures, guidelines, and programs that enable the conduct of research while ensuring compliance with regulatory requirements.
• Coordinating internal compliance review and monitoring activities, including periodic reviews of policies and programs.
• Developing, coordinating, and participating in a multi-faceted educational and training program that focuses on the elements of the compliance program and that seeks to ensure that all appropriate faculty and teammates are knowledgeable about pertinent policies and federal and state research standards.
• Participating in investigation of matters related to compliance, including designing and coordinating internal investigations (e.g., with Office of Research / CTSI and/or OGC) and any resulting corrective action.
• Overseeing and monitoring the implementation of specific compliance program elements.
• Acting as the Enterprise Compliance representative for assigned research related committees
• Continuing to enhance knowledge of complex compliance issues, laws and regulations relating to research compliance
• Exercising highly effective interpersonal skills for working closely with internal parties (including the Office of Research / CTSI) and for effective representation of the Enterprise Compliance Office’s positions on issues with internal and external groups
• Working independently on multiple issues concurrently and to exercise independent judgment in establishing priorities; ability to organize work, make sound decisions and exercise good judgment.

Physical Requirements

Involves travel to and from the office to other facilities within the Enterprise, as well as to companies with which the Enterprise does business. Lifting and moving reports and notebooks weighing up to ten pounds. Majority of day is spent sitting.

Education, Experience and Certifications

• Bachelor’s degree from an accredited college or university in business, accounting, nursing or related field is required. 
• A Juris Doctorate, Master’s in Business Administration or a Master’s in Health Administration is preferred. 
• Five (5) years of experience in a university, academic medical center or a research health system, with a focus on research compliance activities is required. 
• Certification in Healthcare Research Compliance (CHRC) is strongly preferred.