Clinical Regulatory Coordinator II

Come join TriHealth as a Clinical Regulatory Coordinator II! 

TriHealth offers a mission‑driven environment where regulatory professionals can make a meaningful impact on the integrity and success of clinical research. As a Clinical Regulatory Coordinator II, you play a central role in ensuring every study meets the highest standards of compliance, ethics, and patient protection. You’ll serve as the primary regulatory contact across the full clinical trial lifecycle - preparing submissions, managing IRB communications, maintaining essential documents, and supporting internal and sponsor audits. Your expertise directly strengthens the quality, safety, and credibility of the research that shapes patient care across our system.

What sets TriHealth apart is our commitment to supporting professionals who take pride in precision, collaboration, and purpose‑driven work. You’ll partner closely with investigators, research nurses, sponsors, and cross‑functional teams in an environment that values initiative, problem‑solving, and continuous learning. TriHealth is consistently recognized as a great employer because we invest in our people, foster a culture of respect and teamwork, and empower you to grow your career while contributing to research that truly matters. This is a place where your regulatory expertise is not only valued - it’s essential to advancing healthcare in our community.

Apply today and grow your career with a team that truly values you.

Location:

• Good Samaritan Hospital Lab at 375 Dixmyth Avenue, Cincinnati, OH 45220

Work Schedule: 

• Full-Time (80 hours bi-weekly)

• Day Shift

• No Weekend, Holiday or On Call Commitment

Benefits: 

TriHealth offers aa comprehensive benefits package including medical, dental, vision, paid time off, retirement plans, and tuition reimbursement. Please view our benefits page https://careers.trihealth.com/what-we-offer/benefits

Job Requirements:

• Bachelor's Degree 

• Equivalent experience accepted in lieu of degree 

• Medical terminology 

• Proficient in Microsoft Office 

• Demonstrated knowledge & understanding of human research policies, regulations, procedures & standards according to HIPAA, IRB, FDA, ICH, & GCP guidelines, Sponsor regulatory requirements

• 1-2 years’ experience Professional

Job Overview:

The Research Regulatory Coordinator II serves as an integral part of the research team and is the primary contact for all regulatory activities of research studies throughout the clinical research life cycle of assigned protocols. The individual should exemplify the TriHealth mission, vision and values and acts in accordance with TriHealth, IRBs, and FDA policies and procedures. This position supports the set-up and conduct of all phases of clinical trial research as needed, including but not limited to the review and preparation of new study submission applications, site informed consent/HIPAA forms, collection and maintenance of regulatory documents, preparation and submission of local and central/commercial IRB applications and modifications, tracking of IRB approvals, completion of continuing review reporting, and preparation and assistance with internal and sponsor monitoring visits. Perform clinical and logistical review of protocols and apply knowledge to job requirements.

Job Responsibilities:

• Collaborates with the study team and sponsors in the preparation and submission of applications and documents based on local and central/commercial IRB recommendations of new studies, study amendments, and continuing reviews. 

• Proficient in the tracking of all IRB approvals. Assures IRB/regulatory compliance in facilitating communication between study sponsor, IRB, principal investigator, and study subjects as indicated. 

• Assures compliance with standards and deadlines in notification of subject registration, enrollment, and decision to end participation in study when indicated. 

• Follows standard procedures and meets deadlines for submissions of progress reports and external