Remote Clinical Research Regulatory Specialist I

University of Cincinnati; Cincinnati (OH); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Tuition remission

Comprehensive health coverage

6 weeks paid parental leave

Job summary

University of Cincinnati is hiring a Clinical Research Regulatory Specialist I in the College of Medicine. The role focuses on managing regulatory operations for assigned studies, coordinating IRB submissions, and ensuring compliance across federal and internal policies.

Remote work with some on-site requirements is possible. The position requires a Bachelor's degree and 1–2 years of experience, with certifications like SOCRA/ACRP considered.

Qualifications

• Bachelor's degree required.
• 1–2 years of relevant regulatory experience.
• SOCRA or ACRP certification considered.
• Strong knowledge of GCP, IRB procedures, and regulatory compliance.

Responsibilities

• Prepare and submit protocol documents to IRBs and regulatory bodies.
• Serve as liaison for designated protocols with sponsors, CROs, and internal teams.
• Interpret and apply federal, state, and local regulations to ensure ethical research practices.
• Maintain regulatory documents in Complion and secure storage systems.
• Coordinate site visits and sponsor communications with supervision.
• Support development and execution of research agreements and contracts.

Skills

Regulatory submissions

IRB coordination

Regulatory knowledge (FDA/CF

Regulatory documentation

Stakeholder liaison

Education

Bachelor's Degree

Tools

Complion

Job description

University of Cincinnati is hiring a Clinical Research Regulatory Specialist I in the College of Medicine. The role focuses on managing regulatory operations for assigned studies, coordinating IRB submissions, and ensuring compliance across federal and internal policies.

Remote work with some on-site requirements is possible. The position requires a Bachelor's degree and 1–2 years of experience, with certifications like SOCRA/ACRP considered.