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SENIOR REGULATORY COMPLIANCE CONSULTANT
Job Title: SENIOR REGULATORY COMPLIANCE CONSULTANT
Job Code: 2861
FLSA: E
Job Level: 16
Revised Date: 11/01/2024
Job Family: JF 28
Occupational Summary
Provide good practices and regulatory compliance expertise to Duke research units. Direct a variety of activities for the quality assurance and regulatory compliance group. Implement a compliance strategy to ensure compliance with all applicable regulatory requirements and make recommendations regarding the specific activities and resources required to support this strategy. Conduct internal and external audits and train staff on proper conduct of audits.
Work Performed
Provide guidance to team members, oversee process and oversight outcomes, streamline workflow prioritization and assignments, and adhere to established policies and standard operating procedures.
Conduct audits and reviews of protocol processing, postapproval monitoring, facility inspection, animal welfare investigations, and internal/external reports and documents to ensure adherence to established policies, SOPs, and other internal/external oversight requirements (e.g., regulatory, governmental, funding).
Reviews will be risk-based and encompass assessments of the culture of compliance, adherence to processes, training, monitoring, response to identified issues, and process/regulatory burden balancing.
Perform inspections and clearances associated with external collaborations, human care areas, grant requirements, and other clearance items according to established policies and SOPs.
Stay abreast of affiliated internal Duke requirements and external regulatory, funding, policy, and accreditation requirements to include current publications, and assist the Director in incorporating new requirements into Animal Program processes.
Serve as the authoritative source on business process and compliance expectations and activities, consistently staying abreast of emerging issues, evolving and emergency regulatory requirements, and modifications to Duke policies, procedures, and processes.
Promote increased compliance awareness to the Duke community, instill the value of process change where necessary and identify opportunities to strengthen the university's risk mitigation strategy.
Build and maintain strong customer relationships through collaboration and institutional community involvement and be recognized as a solution- driven, trusted advisor.
Conduct due diligence to explore potential issues, validate their implications, and provide insightful analysis and strategic solutions.
Furnish regular status updates for the director, coordinating reviews and addressing queries or concerns.
Educate and train team members and members of the research community on current and new processes and workflows to facilitate knowledge sharing within the team and promote a comprehensive understanding of processes, requirements, risks, and effective solutions.
Help lead the teams seamless transition to cutting-edge electronic engagement tools, ensuring a streamlined and efficient adoption process.
Work with leadership to review and refine internal processes and manage processes, focusing on maintaining regulatory and oversight requirements, increasing efficiency, and decreasing researcher burden.
Respond promptly to external and internal concerns, implementing corrective actions as appropriate.
Contribute to external outreach and department training initiatives.
Serve as a liaison and provide customer service.
Oversee and supervise the team groups based on unit needs to ensure all required job functions are complete and accurate, including developing and implementing procedures, processes, services, and systems to accomplish requirements and goals.
Train team members in proper methods and procedures to ensure correctness of work.
Provide staff leadership. Approval authority of staff timesheets and maintenance of time off calendar.
Recommend various personnel actions including, but not limited to, hiring, performance appraisal, promotions, transfers, and vacation schedules.
Embrace other related duties and manage different projects incidental to the work described herein. Percent effort may vary based on need.
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.
Required Qualifications at this Level
Education/Training
Bachelor Degree. A master or higher is preferred.
Experience
The position requires at least eight years of relevant compliance, audit, or consulting experience.
Skills
Valuable professional attributes include risk based internal controls and compliance experience, in depth knowledge of business processes, strong relationship-building skills, confident communication style, appropriate assertiveness, diplomacy, personal initiative, and the ability to facilitate collaboration across all levels of the institution and research community. Preferred attributes include the ability to provide guidance and direction to the team, including setting standards and monitoring performance; using logic and reasoning to identify the strengths and weaknesses of alternative solutions to problems; skills in evaluating program performance, summarizing findings, communicating results, and forming an action plan; knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, and coordination of people and resources. Experience with MS Access, Adobe, PowerPoint, and Excel preferred.
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy related conditions), sexual orientation, or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
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.
