IRB​/Regulatory Specialist

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 RESPONSIBLITIES:

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…