"Research Compliance Specialist, College of Medicine, Department of Emergency Medicine"

Job Overview

As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. In partnership with the UC Health academic healthcare system and Cincinnati Children’s Hospital Medical Center, the College of Medicine’s faculty are transforming the world of medicine every day and are nationally recognized are leaders in clinical teaching and research.

The Research Compliance Specialist is responsible for managing and maintaining regulatory compliance for clinical and/or basic research studies within the Department of Emergency Medicine. This role ensures all research activities adhere to institutional policies, federal regulations, sponsor requirements, and ethical standards for human subjects’ protection. The Research Compliance Specialist works closely with investigators, research staff, and regulatory agencies to prepare, submit, and maintain study documentation throughout the research lifecycle.

Essential Functions

• Prepare, submit, and maintain Institutional Review Board (IRB) applications, amendments, continuing reviews, and reportable events.
• Ensure all research activities comply with federal, state, and institutional regulations
• Maintain accurate and current regulatory binders and essential study documents.
• Track and monitor study approvals, expirations, and renewals to ensure ongoing compliance.
• Assist with regulatory start-up activities for new studies, including preparation of informed consent forms and recruitment materials.
• Coordinate with sponsors, contract offices, and investigators to ensure all regulatory requirements are met prior to study initiation.
• Maintain electronic and paper regulatory files in accordance with institutional and sponsor guidelines.
• Ensure documentation of investigator qualifications, study delegation logs, and training certifications are complete and up to date.
• Serve as a liaison between the research team, IRB, sponsors, and regulatory agencies.
• Communicate regulatory requirements and updates to investigators and research staff.
• Provide guidance on Good Clinical Practice (GCP) and human subjects protection standards.
• Prepare for and assist with internal audits, monitoring visits, and external inspections.
• Respond to audit findings and implement corrective actions as needed.
• Perform related duties based on departmental need. This job description can be changed at any time.

Required Education

• Bachelor’s Degree must be in a related field.
• Six (6) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Required Experience

Two (2) years of experience in a compliance, basic science and/or clinical research environment.

Additional Qualifications Considered

Relevant professional certification or an advanced degree.

Physical Requirements/Work Environment

• Office environment/no specific unusual physical or environmental demands.

Compensation and Benefits

UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. (UC Benefits Link) Highlights include:

Comprehensive Tuition Remission

UC provides tuition remission for you and your eligible dependents, covering tuition costs for nearly all undergraduate and graduate programs offered by the university.

Robust Retirement Plans

As a UC employee, you won’t contribute to Social Security (except Medicare). Instead, you’ll choose between state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP), with UC contributing 14–18% of your salary based on position.

Real Work-Life Balance

UC prioritizes work-life balance with a generous time-off policy, including:

• Vacation and sick time
• 11 paid holidays and additional end-of-year paid time off (Winter Season Days)
• 6 weeks of paid parental leave for new parents

Additional Benefits Include:

• Competitive salary based on experience
• Comprehensive health coverage (medical, dental, vision, prescription)
• Flexible spending accounts & wellness programs
• Professional development & mentorship opportunities

To learn more about why UC is a great place to work, please visit our careers page at <https://www.uc.edu/careers.html>