Clinical Research Regulatory Specialist

OhioHealth; Columbus (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

OhioHealth is seeking a Regulatory Consultant to oversee pre-award and post-award regulatory activities for clinical trials and research projects. The role requires coordinating with investigators, ensuring compliance with GCP, and maintaining regulatory documents across OhioHealth sites.

The ideal candidate will have a Bachelor’s degree and 2+ years in a hospital/clinical or administrative setting, with strong IRB knowledge and attention to regulatory detail.

Qualifications

• Bachelor’s degree required.
• 2 years of hospital/clinical or administrative experience preferred.
• Strong knowledge of Good Clinical Practices (GCP) and IRB processes.

Responsibilities

• Provide regulatory management oversight for pre-award and post-award activities for clinical trials and research projects.
• Coordinate with research nurses and physicians to implement study procedures and educate staff on data collection and regulatory recordkeeping.
• Liaise with Institutional Review Board on ethical matters and respond to IRB correspondence and determinations.
• Assist in audit preparedness and monitor visits, maintaining study files per sponsor and regulatory requirements.
• Develop reporting metrics and generate ad hoc reports to support research administration.

Skills

Regulatory oversight

GCP knowledge

IRB liaison

Regulatory filing

Project coordination

Education

Bachelor's Degree

Tools

Regulatory databases

Job description

OhioHealth is seeking a Regulatory Consultant to oversee pre-award and post-award regulatory activities for clinical trials and research projects. The role requires coordinating with investigators, ensuring compliance with GCP, and maintaining regulatory documents across OhioHealth sites.

The ideal candidate will have a Bachelor’s degree and 2+ years in a hospital/clinical or administrative setting, with strong IRB knowledge and attention to regulatory detail.