IRB/Regulatory Specialist (32550)

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

Position Summary

An IRB Regulatory Specialist is needed to continue building a growing research department across multiple clinical trial sites that Urology Alliance operates. The role involves ensuring the ethical and regulatory compliance of clinical research activities. You would work closely with Urology Alliance PIs, Sub-Is, and CRCs on various studies for continuous improvement of regulatory processes. You will be working with highly motivated large private practice urology groups with 10-40+ providers. This position is hybrid and may require up to 25% travel.

Job Relationships

• Reports to Regulatory Manager and Director of Strategy and Operations.
• Able to collaborate with all of the Urology Alliance Research teams, CROs, sponsors, IT, patient navigators, and 3rd party vendors.

ROLE QUALIFICATIONS: (experience, education, and skills)

• Must have knowledge of and experience with relevant federal and state regulatory guidelines.
• Must have > 5yrs experience with conducting clinical trials.
• Urology based clinical experience preferred.
• Experience with evaluating and implementing study protocols.
• Certification via ACRP or the equivalent preferred.
• Proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems.
• Effective time management and the ability to prioritize work.
• Excellent written and verbal communication skills and the ability to interact with all levels of management, staff, and physicians.

Essential Job Responsibilities

• Collaborate with Urology Alliance research teams to ensure proper submissions, review, approval, and maintenance of research protocols by the Institutional Review Board (IRB).
• Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA, sponsors, and other institutional and federal oversight committees, including drafting, and reviewing content as appropriate
• Prepare and submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional and federal regulations.
• Maintain study regulatory filing systems (paper and electronic)
• Monitor ongoing studies to ensure compliance with IRB-approved protocols and applicable regulations.
• Conduct comprehensive reviews of research documentation, including informed consent forms, recruitment materials, and study procedures, to ensure accuracy and compliance.
• Provide guidance to researchers on regulatory requirements, ethical considerations, and best practices in clinical research.
• Lead study start-up: prepare and submit all required regulatory documents for new study applications to ensure successful trial launch
• Independently follow-up and resolve all issues related to regulatory concerns identified during monitor visits.
• Prepare and submit modifications / amendments, and continuing renewals for ongoing study maintenance in a timely manner
• Conduct study close-out and be accountable for the archiving process which includes ensuring all study related files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines, and program SOPs.
• Process safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate
• Report non-compliance and unanticipated problems
• Serve as primary resource for Urology Alliance research teams, CROs, and sponsors and provide guidance on regulatory statuses, approvals, and instructions regarding patient consent.
• Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team.
• Monitor GCP and IATA training and track certification expirations for MSO research teams to ensure up-to-date knowledge of FDA, GCP, ICH, federal and state regulations

Performance Requirements

Knowledge

• Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements.
• Understanding of medical terminology.

Skills

• Ability to use multi-line phone systems and basic computer systems.
• Interpersonal and communication both with internal staff and external customers.
• Skill in evaluating and implementing study protocols and budgets.
• Skill in reading medical chart terminology.
• Time Management.

Abilities

• Ability to communicate effectively with staff, and external contacts via phone, in person, and through electronic mail.
• Elicit appropriate information for patients to clinic staff.
• Ability to read and understand information and ideas presented in writing.
• Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.

Reporting to this position

No direct reports at this time, can change as department grows

Physical Demands And Work Environment

• Physical demands: Involves sitting approximately 90 percent of the day, walking or standing for the remainder. Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up to 20 pounds.
• Work environment: Primarily office setting. Noise level in the work environment is usually moderate. Clean, well-lighted office environment.