Regulatory Compliance Specialist

2 weeks ago

Dallas, Texas, United States Baylor Scott & White Healthcare Full time
JOB SUMMARY

The Regulatory Affairs Specialist plays a crucial role in providing regulatory oversight, guidance, and administrative support to various committees involved in research activities at Baylor Scott & White Healthcare.

ESSENTIAL FUNCTIONS OF THE ROLE
  • Evaluate all submissions to the Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) to ensure that all required documentation is complete and meets regulatory standards.
  • Assess consent documents for regulatory compliance and ensure they are articulated at an appropriate readability level.
  • Confirm that researchers and their teams have the necessary qualifications and training to conduct research involving human or animal subjects.
  • Maintain comprehensive records to demonstrate that all IRB and/or IACUC operations are in alignment with regulations and applicable AAHRPP standards.
  • Support the Research Quality Improvement Specialist in overseeing BRI-sponsored clinical trials in accordance with Federal Guidelines and Good Clinical Practice (GCP) by participating in monitoring visits.
  • Assist in conducting targeted monitoring visits on behalf of the IRB, IACUC, or BRI Administration.
  • Contribute to the development and implementation of an extensive education and training program for IRB Members, IACUC Members, Investigators, and Research Staff, including creating presentations on regulatory matters, tip sheets, and updates.
  • Support the accreditation process and ongoing quality assessments necessary to uphold AAHRPP accreditation status.
  • Stay informed about changes in federal and state regulations affecting human and animal research to provide accurate guidance to IRB Members, Researchers, and Research Staff.
  • Offer regulatory advice to Principal Investigators (PIs) and Research Staff to facilitate the submission of compliant materials to the IRB or IACUC.
  • Provide regulatory support to the Research Conflict of Interest Committee, including tracking financial relationships and ensuring compliance with management plans.
  • Disseminate policy updates and regulatory guidance to IRB and IACUC Members to ensure a compliant review process for all submissions.
KEY SUCCESS FACTORS
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
  • Strong communication and organizational abilities.
  • Able to manage multiple responsibilities and work independently with minimal supervision.
BENEFITS

Baylor Scott & White Healthcare offers a competitive benefits package that includes:
  • Immediate eligibility for health and welfare benefits.
  • 401(k) savings plan with a dollar-for-dollar match up to 5%.
  • Tuition Reimbursement.
  • PTO accrual starting from Day 1.
QUALIFICATIONS

- EDUCATION - Bachelor's degree or equivalent experience beyond the minimum qualifications.

- EXPERIENCE - Minimum of 2 years of relevant experience.

- Preferences: Experience in healthcare settings and familiarity with iRIS.

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