Clinical Trials Regulatory Specialist (IRB)

Paycom; Austin (TX); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Urology Alliance seeks an IRB Regulatory Specialist to extend a growing research department across multiple clinical trial sites. You will ensure ethical and regulatory compliance of clinical research activities, collaborating with PIs, Sub-Is, and CRCs on various studies for continuous improvement of regulatory processes.

This hybrid role may require up to 25% travel and involves close work with CROs, sponsors, IT, patient navigators, and 3rd party vendors to support compliant, high-quality

Qualifications

• Must have knowledge of federal and state regulatory guidelines.
• Over 5 years of clinical trials experience.
• ACRP certification or equivalent preferred.

Responsibilities

• Collaborate with research teams to ensure IRB submissions and maintenance.
• Prepare and maintain regulatory documentation for IRB, FDA, sponsors, and oversight bodies.
• 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 IRB-approved protocol compliance.
• Lead study start-up: prepare and submit regulatory documents for new studies.

Skills

Regulatory knowledge

Clinical trials experience

EMR proficiency

Practice Management systems

MS Office

Time management

Communication skills

Prioritization

Cross-functional collaboration

Education

ACRP certification

Bachelor-or-higher in life sciences/healthcare

Tools

EMR

Practice Management Systems

Microsoft Office

Job description

Urology Alliance seeks an IRB Regulatory Specialist to extend a growing research department across multiple clinical trial sites. You will ensure ethical and regulatory compliance of clinical research activities, collaborating with PIs, Sub-Is, and CRCs on various studies for continuous improvement of regulatory processes.

This hybrid role may require up to 25% travel and involves close work with CROs, sponsors, IT, patient navigators, and 3rd party vendors to support compliant, high-quality