Identify and rank areas at risk of exposure to Compliance Officer and recommend strategies to address such issues. Develop systems and relationships to support auditing activity in collaboration with the compliance officer; organize panels of experts to assist in reviews and analysis.

Identify and report general compliance issues that may arise through the work process; write and revise standard operating procedures.

Review technical publications, articles and abstracts to stay abreast of current regulations and trends, ensure appropriate actions are taken to incorporate necessary revision into workplace environment.

Collaborate with and advise the institutional conflicts of interest committee on management plans.

Serve as liaison to other institutional monitoring and audit groups.

Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Education

Work generally requires a bachelor's degree in a biological Science.

Experience

Work requires six years of experience quality assurance or quality control related to clinical trials. A Master's degree in a related field may be substituted for 2 years of required experience OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.