Clinical Trials Compliance Coordinator

Socket.dev; Tennessee; On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Employee Assistance Program (EAP)

Job summary

U.S. Urology Partners is seeking a Clinical Research Regulatory Coordinator to maintain regulatory documents and ensure sites adhere to ICH-GCP guidelines. The role involves coordinating submissions, inspections, and staff certifications while working with clinical research teams in a dynamic setting.

The ideal candidate will be highly organized, possess excellent communication skills, and be willing to travel to U.S. urology sites to review regulatory activities.

Qualifications

• Bachelor's degree in a related field is required.
• Excellent written and spoken communication.
• Strong organization and multitasking abilities.
• Experience in clinical research project management.
• Willingness to travel to other sites to ensure compliance.

Responsibilities

• Organize and maintain study documents
• Oversee staff and site 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
• Collaborate 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

Excellent verbal and written comm.

High level of organization

Experience in project management

Microsoft Office (Word, Excel)

Willingness to travel

Education

Bachelor's degree in related field

Tools

Microsoft Office

Job description

U.S. Urology Partners is seeking a Clinical Research Regulatory Coordinator to maintain regulatory documents and ensure sites adhere to ICH-GCP guidelines. The role involves coordinating submissions, inspections, and staff certifications while working with clinical research teams in a dynamic setting.

The ideal candidate will be highly organized, possess excellent communication skills, and be willing to travel to U.S. urology sites to review regulatory activities.