Research Compliance Specialist

The Research Compliance Specialist is primarily responsible for administering Case Western Reserve University's conflict-of-interest (COI) policies, procedures, and workflows to ensure compliance with federal regulations, sponsor requirements, and institutional expectations. This position will drive operational workflows and provide support for the full life cycle of individual and institutional COI review, management, monitoring, and reporting. This position manages COI Committee operations, oversees the university's electronic COI disclosure system, and serves as a key resource to faculty, staff, investigator, and affiliate partners. The position will also assist, as needed, with operations and workflow of the related Responsible Conduct of Research program.

ESSENTIAL FUNCTIONS

Drive the operational needs of the conflict-of-interest program. Administer the university's conflict of interest (COI) disclosure processes, including intake, review, tracking, and follow-up to ensure compliance with institutional and regulatory requirements. Conduct preliminary assessments of COI disclosures, identify potential conflicts, and prepare documentation and recommendations for review by the COI Committee. Maintain COI records, databases, and reporting systems to ensure accurate, timely, and auditable compliance documentation. Use AI tools for efficiency and automation when possible. (50%) Manage the reporting requirements and follow up to our federal sponsors in conflict of interest, ensuring compliance to each sponsor. Keep organized and audit ready records. Develop and maintain standard operating procedures. Participate with and support the Executive Director of Research Compliance in communicating COI requirements and best practices to all university stakeholders through announcements, education, recording training as needed. Support department initiatives related to research integrity, compliance, education, including special projects and process improvements. (30%) Assist, as needed and directed, with operations and workflow of the related Responsible Conduct of Research program. Crosstrain in this area to ensure seamless coverage if needed for operational surges and the like. (15%)

NONESSENTIAL FUNCTIONS

Perform other duties as assigned. (5%)

CONTACTS

Department: Daily contact with Executive Director of Research Compliance and Research Compliance Specialist. Regular contact with department leadership. University: Regular contact with the faculty and staff, and occasionally students. External: Frequent contact with faculty and research staff involved in research at affiliated institutions.

SUPERVISORY RESPONSIBILITY

Not applicable.

QUALIFICATIONS

Experience: 3 to 5 years of related work experience required. Education: Bachelor's degree required.

REQUIRED SKILLS

Strong reasoning skills with the ability to evaluate nuanced information, identify risks, and recommend appropriate actions. Ability to assess processes, identify areas for improvement, and contribute to the development of more efficient and effective compliance practices. Excellent written and verbal communication skills, including the ability to explain complex requirements clearly to varied audiences. Strong organizational skills with the ability to manage multiple tasks, deadlines, and priorities in a fast-paced research environment. Demonstrated commitment to confidentiality, ethical conduct, and the responsible stewardship of sensitive information. Able to use computer and AI software to automate tasks, create templates, conduct analysis on new regulatory requirements, and otherwise streamline processes. Ability to demonstrate successful support, education, and advocacy for all students, aligned with the values, mission, and messaging of the university, while adhering to the staff policy on conflict of commitment and interest. Ability to meet consistent attendance. Ability to interact with colleagues, supervisors, and customers face to face.

WORKING CONDITIONS

Standard office environment. #J-18808-Ljbffr