Hybrid IRB & Regulatory Specialist — Clinical Trials

GI Alliance; Austin (TX); Hybrid; USD 95,000 - 130,000; Full time

Job summary

GI Alliance is seeking an IRB Regulatory Specialist to help build and support a growing research department across multiple clinical trial sites operated by Urology Alliance. The role focuses on ensuring ethical and regulatory compliance of clinical research activities and collaborating with PIs, Sub-Is, and CRCs.

The position is hybrid and may require up to 25% travel, coordinating with study teams, sponsors, CROs, and vendors while maintaining regulatory filings and adherence to GCP and FDA

Qualifications

• Knowledge of federal and state regulatory guidelines.
• Over 5 years of experience conducting clinical trials.
• Urology-based clinical experience preferred.
• Experience evaluating and implementing study protocols.
• ACRP certification or equivalent preferred.
• Proficiency with Microsoft Office, EMR, and Practice Management systems.
• Strong time management and prioritization.
• Excellent written and verbal communication with all levels.

Responsibilities

• Collaborate with research teams to ensure submissions, review, approval, and maintenance of protocols by the IRB.
• Prepare, track, and maintain regulatory correspondence and documents for IRB, FDA, sponsors, and other oversight committees.
• Prepare and submit regulatory documents to IRB and governing bodies to maintain GCP compliance.
• Maintain study regulatory filing systems (paper and electronic).
• Monitor ongoing studies to ensure compliance with IRB-approved protocols and applicable regulations.
• Review informed consent forms, recruitment materials, and study procedures for accuracy and compliance.
• Provide guidance on regulatory requirements and best practices in clinical research.
• Lead study start-up: prepare and submit all required regulatory documents for new study applications.
• Independently follow-up and resolve regulatory concerns identified during monitor visits.
• Prepare and submit amendments/continuing renewals for ongoing study maintenance in a timely manner.
• Conduct study close-out and archive files per FDA and SOPs.
• Process safety reports and submit to IRB as appropriate.
• Report non-compliance and unanticipated problems.
• Serve as primary resource for teams, CROs, sponsors on regulatory statuses and instructions regarding patient consent.
• Stay updated on regulatory changes and disseminate knowledge to study/operations team.
• Monitor GCP and IATA training and track certifications for MSO research teams.

Skills

Regulatory guidelines

Clinical trials

Urology exposure

Study protocols

ACRP certification

MS Office

EMR

Practice Management

Time management

Communication skills

Education

ACRP certification (preferred)

Tools

EMR systems

Practice Management

Microsoft Office

Job description

GI Alliance is seeking an IRB Regulatory Specialist to help build and support a growing research department across multiple clinical trial sites operated by Urology Alliance. The role focuses on ensuring ethical and regulatory compliance of clinical research activities and collaborating with PIs, Sub-Is, and CRCs.

The position is hybrid and may require up to 25% travel, coordinating with study teams, sponsors, CROs, and vendors while maintaining regulatory filings and adherence to GCP and FDA