Senior IRB Regulatory Analyst

Job Purpose

Internal title: Senior Research Subject Protection Analyst

External title: Senior IRB Regulatory Analyst

Provides team leadership and training to the team of Research Protections Analyst in support to the functions of various programs in research and subject protections. Provides analytical and programmatic support to the research subject protections program.

Job Duties

• Provide leadership and training for the team of analysts.
• Support one board/month and corresponding Institutional Review Board (IRB) or Data Safety and Monitoring Board (DSMB) or Institutional Animal Care and Use Committee (IACUC) actions for that board.
• Maintain positive working relationship with chair, vice-chair and board members.
• Provide customer service and education to IRB/DSMB members and Principal Investigators for protocols assigned to board.
• Preview all protocol/consent forms.
• Provide expedited approvals/exemptions with supervision by the chair/senior analyst.
• Recommend revision and action for requirements to Principal Investigator/Administrative Contact.
• Establish anticipated quorum for each meeting.
• Assign protocols according to IRB/DSMB/IACUC member attendance and expertise.
• Serve as point of contact when IRB/DSMB/IACUC members identify protocol issues that merit 'table' or disapproval.
• Assure key ethical/regulatory issues are adequately discussed in full board meetings.
• Prepare minutes.
• Review replies for completion of modifications according to full board criteria for administrative review and approval of minor amendments.
• Serve on quality improvement/accreditation teams as requested.

Minimum Qualifications

• Bachelor's degree in Business Administration, Health Care Administration or related field.
• Four years of related experience may substitute for degree requirement.
• Four years of relevant experience.

FLSA Status

Exempt

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

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