Under the general direction and supervision of the Vanderbilt University Medical Center Chief Compliance Officer, the Research Compliance Officer works directly with the Vanderbilt University Medical Center (VUMC) Office of Healthcare Compliance and with the senior VUMC leaders for research to maintain and continuously improve an effective compliance program to prevent and detect potential regulatory compliance issues. The Research Compliance Officer will be responsible for the optimization of, and guidance related to, regulatory activities and operational procedures involved with the monitoring and compliance requirements for the biomedical research enterprise.
KEY RESPONSIBILITIES
Consultation. Represent the research compliance function in advice to VUMC leadership and process improvement analysis.
Knowledge. Maintain extensive and current knowledge of health care research compliance laws and regulations relating to: human and animal subject protection, clinical trial agreements and contracts, sponsored programs, pre- and post-award finance, export control, research integrity, conflict of interest, environmental health and safety, and other research compliance issues .
Liaison. Support the work of the Research Compliance Committee in assessing and addressing research compliance risks throughout VUMC. Assist as a liaison between external regulatory auditors and reviewers, and operational units.
Policy Development. Coordinate groups and functions to develop and maintain effective and clear policies and procedures applicable to the research enterprise.
Internal Controls. Review and recommend controls and processes implemented by employees and systems to verify appropriate operations.
Inquiries. Work with stakeholders to respond to and assist with investigations into research compliance issues, as appropriate.
Collaboration. Facilitate communication among the VUMC Office of Healthcare Compliance and research operations with respect to other compliance functions, such as education and auditing and monitoring, to minimize regulatory risk and maximize research, financial, and administrative efficiency.
At least 10 years relevant experience as a Research Compliance or Ethics Officer, health care attorney, or equivalent
A Juris Doctor
Bachelor's Degree or equivalent experience in a STEM field
Certification in Healthcare Research Compliance (CHRC)
Certification of successful completion of the Vanderbilt Program for Research Administration Development (VPRAD)
Knowledge of the Compliance risks associated with a broad array of biomedical research regulators including, but not limited to, the Office for Human Research Protections, the Office of Laboratory Animal Welfare, the Occupational Health & Safety Administration, the Uniform Guidance, and other applicable state, federal, and private agencies
Prior experience working with state and federal regulatory and law enforcement agencies to resolve Compliance disputes successfully
Prior management supervisory experience
Excellent communication and organizational skills
Demonstrated ability to plan, manage and work independently on large projects and initiatives
*CA
Internal Number: 2003739
About Vanderbilt Health
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period.Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As th...e largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.
