Responsible for promoting best practices and solutions, the Research Compliance Specialist contributes to the success of the Research Programs by assisting with the development, oversight and monitoring of research compliance processes to promote and facilitate compliance with laws and regulations, ethical, practice and care standards, KU policies and procedures, and approved protocols.
Key Roles & Responsibilities
• Oversee research compliance function, including research conflict of interest, animal welfare, export control and human subjects.
• Carry out routine and post approval monitoring and activities related to protocol review
• Conduct risk assessments
• Participate in the development and implementation of programs to ensure compliance with required regulations and laws, including government-mandated requirements
• Provide guidelines to investigators to assure compliance with research regulations and standards
• Assist with development and implementation of policies, procedures, and practices designed to promote compliant practices and mitigate risk
• Facilitating compliance with decisions and corrective actions
• Coordinate compliance committees,and may act as an ex-officio or regular member as appropriate.
• Follow set policies, processes and procedures to ensure research compliance objectives are met.
• Prepare summary reports to inform management on matters of research compliance including potential areas for concern, recommended actions, and level of support needed.
• Perform research on best practices for research compliance.
• Implement training programs that are complete and relevant at regular intervals for all members of the research community, including department administrators, finance officers, transaction processors, research project and laboratory managers, and research project leaders.
• Develop and conduct assessments and usability evaluations for tools, services and trainings.
• Collect, organize, and review documentation related to individual, group, and institutional compliance requirements
• Ensure accurate management of records for regulatory review, membership and registrations.
• Adhere to the University's information security and confidentiality policies and procedures, and report breaches or other security risks accordingly
• Coordinate with other departments to facilitate the accomplishment of tasks and responsibilities, as and when needed
• Perform any other tasks assigned by the Line Manager
Qualifications & Experience
• A Bachelor s Degree in related field.
• A minimum 5-7 years of relevant experience.
• A minimum of 3-5 years of relevant experience