Clinical Research Regulatory Lead

U.S. Urology Partners; Nashville (TN); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Compassion

Collaboration

Respect

Accountability

Job summary

U.S. Urology Partners seeks a Clinical Research Regulatory Coordinator to maintain regulatory documents, ensure ICH-GCP compliance across sites, and support site certifications. The role requires strong organization and communication across clinical research staff and external vendors.

The successful candidate will manage regulatory submissions, prepare sites for inspections, and travel to review regulatory activities, with a collaborative, team-oriented environment and comprehensive benefits.

Qualifications

• 2-5 years of clinical research experience is desirable.
• Excellent verbal and written communication skills.
• High level of organization.
• Experience in project management.
• Proficiency in Microsoft Office (Word, Excel).
• Willing and able to travel to other sites to ensure compliance.
• Attention to detail.
• The ability to manage multiple responsibilities simultaneously.

Responsibilities

• Organize and maintain study documents
• Oversee staff and site related documentation and certifications
• Ensure regulatory compliance by all sites to ICH-GCP guidelines and site operational procedures
• Prepare site for regulatory inspection
• Submit continuing review reports
• Submit new study IRB submissions
• Travel to U.S. Urology Sites to review Regulatory
• Work with Operational Support Specialist during study start-up to provide all necessary documentation for site activation
• Attend meetings as required
• Performs other duties as assigned

Skills

Attention to detail

Verbal and written communication

Organization

Project management

Travel readiness

Education

Bachelor's degree in related field

Tools

Microsoft Office

Job description

U.S. Urology Partners seeks a Clinical Research Regulatory Coordinator to maintain regulatory documents, ensure ICH-GCP compliance across sites, and support site certifications. The role requires strong organization and communication across clinical research staff and external vendors.

The successful candidate will manage regulatory submissions, prepare sites for inspections, and travel to review regulatory activities, with a collaborative, team-oriented environment and comprehensive benefits.