Regulatory Affairs Specialist

1 month ago

Dallas, United States Baylor Scott & White Health Full time

**JOB SUMMARY**

Regulatory Affairs Specialist provides regulatory guidance, monitoring and administrative help to the Institutional Review Board, Institutional Animal Care and Use Committee and Data and Safety Monitoring Board and other people involved in the conduct of research at all Baylor Scott & White Health

**ESSENTIAL FUNCTIONS OF THE ROLE**

+ Review all IRB and/or IACUC submissions to verify the required documents include all necessary information to make regulatory conclusions.

+ Verify consent documents are regulatory compliant and written at the appropriate readability level.

+ Verify that investigators and research staff possess the appropriate education and experience (including IRB and/or IACUC required training) to conduct human or animal research.

+ Maintain documentation sufficient to show that all IRB and/or IACUC activities are conducted in accordance with regulations and applicable AAHRPP standards.

+ Assist the Research Quality Improvement Specialist in monitoring of BRI-sponsored clinical research according to Federal Guidelines and Good Clinical Practice (GCP) by participating in the monitoring visits for verification.

+ Assist the Research Quality Improvement Specialist in conducting directed monitoring visits on behalf of the IRB, IACUC or BRI Administration.

+ Assist in the implementation of a comprehensive education and training program for IRB Members, IACUC Members, Investigators and Research Staff. This includes development of presentations regarding regulatory issues, tip sheets, regulatory updates, curriculum, BLN modules and other training opportunities.

+ Assist in the application process and ongoing quality monitoring required to maintain accreditation status with AAHRPP.

+ Keep current on all developments and changes in federal and state regulations and requirements impacting human subject research and animal research in order to serve as a resource to IRB Members, Researchers and Research Staff with regard to the conduct of research involving human subjects and animals in research.

+ Provide regulatory guidance to PI's and Research Staff to help the successful submission of regulatory compliant materials that are approved by the IRB or IACUC as applicable.

+ Provide regulatory guidance to the Research Conflict of Interest Committee including tracking of investigator financial relationships, management plans and necessary changes needed to comply with the plans.

+ Distribute policy information and other regulatory guidance to IRB and IACUC Members to facilitate a regulatory compliant review of all submissions to the IRB and IACUC.

**KEY SUCCESS FACTORS**

+ Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).

+ Proven communication and organizational skills.

+ Able to multi-task responsibilities and demonstrates ability to work with minimal directions.

**BENEFITS**

Our competitive benefits package includes the following.

+ Immediate eligibility for health and welfare benefits

+ 401(k) savings plan with dollar-for-dollar match up to 5%

+ Tuition Reimbursement

+ PTO accrual beginning Day 1

Note: Benefits may vary based upon position type and/or level

**QUALIFICATIONS**

- EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification

- EXPERIENCE - 2 Years of Experience

-Preferences: Healthcare Experience, Experience with iRIS

As a health care system committed to improving the health of those we serve, we are asking our employees to model the same behaviours that we promote to our patients. As of January 1, 2012, Baylor Scott & White Health no longer hires individuals who use nicotine products. We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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