Clinical Research Regulatory Specialist

United Urology Group; Lakewood (CO); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Tuition reimbursement

Health insurance

Dental insurance

Vision insurance

Corporate discounts

Job summary

United Urology Group in Lakewood, CO is seeking a Clinical Research Regulatory Coordinator to support clinical research teams by facilitating study start-up approvals and maintaining regulatory documentation for human subjects trials.

You will ensure compliance with FDA/NIH/OHRP and ICH GCP, serve as primary IRB/IBC contact, coordinate submissions, and keep staff credentials current, reporting to the Director of Clinical Research.

Qualifications

• High School Diploma required; higher degree preferred as relevant.
• AA/AS or BA/BS degree preferred (or equivalent).
• Current GCP certification.
• ACRP/SOCRA certification preferred.

Responsibilities

• Coordinate regulatory submissions to IRB, IBC, and sponsors.
• Ensure regulatory compliance and up-to-date regulatory files.
• Serve as primary IRB/IBC contact.
• Track protocol approvals through IRB/IBC processes.
• Manage study documents, CRFs, and databases access.
• Assist sponsors with regulatory documents and portals.
• Maintain staff credentials (CVs, licenses, FDFs).
• Participate in teleconferences and investigator meetings.

Skills

Regulatory knowledge

Communication skills

Attention to detail

Interpersonal skills

Writing skills

Time management

Tech literacy

Education

High School Diploma

AA/AS or BA/BS degree preferred

GCP Certification

ACRP/SOCRA certification preferred

Tools

Microsoft Office

EDC systems

CTMS

Job description

United Urology Group in Lakewood, CO is seeking a Clinical Research Regulatory Coordinator to support clinical research teams by facilitating study start-up approvals and maintaining regulatory documentation for human subjects trials.

You will ensure compliance with FDA/NIH/OHRP and ICH GCP, serve as primary IRB/IBC contact, coordinate submissions, and keep staff credentials current, reporting to the Director of Clinical Research.