Clinical Research Regulatory & Start-Up Lead

HorseShoe Beverage Company; Nashville (TN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Company-Paid Holidays

Vacation and Sick Time

PTO (16 hrs. annually)

Medical, Dental and Vision Insurance

Basic Life Insurance: Company-paid

Long-Term Disability Insurance:Company

Health Savings Account Options

Retirement Benefits: profit-sharing

Job summary

Urology Associates, P.C. in Nashville, TN is seeking a meticulous Clinical Research Regulatory & Study Start-Up Coordinator to join our on-site Clinical Research Department.

The role centers on regulatory compliance, IRB communications, and TMF management across multiple protocols. This position leads site start-up from feasibility to first patient visit, coordinating sponsor/CRO documentation and ensuring audit-ready records in line with GCP and FDA requirements.

Qualifications

• Bachelor’s degree in life sciences, health sciences or related field preferred.
• 1–2 years of experience in clinical research or regulatory coordination.
• Familiarity with ICH E6 (R2) GCP and FDA regulations (21 CFR Parts 50, 56, 312, 812).
• Experience with IRB submissions and TMF/eTMF documentation.

Responsibilities

• Regulatory management: maintain site regulatory documentation, IRB submissions, and TMF/eTMF integrity.
• Study start-up: coordinate feasibility through first patient visit, including sponsor documents.
• Prepare and submit regulatory documents (FDA 1572, disclosures) and manage timelines.
• Monitor regulatory expirations and support sponsor/CRO visits and audits.
• Collaborate with PI, CRCs, and legal/contracts teams on workflows and SOPs.

Skills

Regulatory coordination

GCP/ICH E6

IRB submissions

TMF/eTMF knowledge

Document management

HIPAA compliance

Education

Bachelor’s degree in life sciences

Associate’s degree considered

Tools

CRIO eRegulatory platform

CTMS

MS Office

eTMF systems

Job description

Urology Associates, P.C. in Nashville, TN is seeking a meticulous Clinical Research Regulatory & Study Start-Up Coordinator to join our on-site Clinical Research Department.

The role centers on regulatory compliance, IRB communications, and TMF management across multiple protocols. This position leads site start-up from feasibility to first patient visit, coordinating sponsor/CRO documentation and ensuring audit-ready records in line with GCP and FDA requirements.