Research Compliance Monitor, IRB

Wayne State University • Detroit, MI

404d • $47,866 - $57,441

About The Position

The Research Compliance Monitor, IRB at Wayne State University is responsible for conducting post-approval monitoring visits to ensure compliance with research regulations involving human participants. This role involves documenting research conduct, submitting reports to the Human Research Protection Program Administration and Institutional Review Boards, and providing guidance to researchers on compliance matters.

Requirements

• Bachelor's degree from an accredited college or university in a related discipline (business, medicine, public health, biomedical, life science, or basic science).
• 2 or more years of experience in a human participant research related job function.
• Basic monitoring or audit experience, and biomedical or pharmaceutical research experience preferred.
• Ability to manage a comprehensive monitoring program.
• Ability to work independently with minimal supervision.
• Ability to analyze and articulate complex scientific and ethical issues.
• Effective communication skills with researchers and colleagues, both verbally and in writing.
• Knowledge of research regulations pertaining to human participant research.
• Skill in using computers and software such as Microsoft Office and institutional specific software.
• Ability to engage researchers and colleagues respectfully.
• Ability to maintain privacy and confidentiality in research and monitoring activities.

Nice To Haves

• Experience in biomedical or pharmaceutical research.

Responsibilities

• Conduct independent post-approval monitoring visits of human participant research protocols.
• Review protocol regulatory documents, informed consent process, and data collection.
• Generate and update research protocol monitoring lists.
• Coordinate and schedule post-approval monitoring visits and follow-up visits as needed.
• Maintain post-approval monitoring report files and communicate findings to the Principal Investigator and relevant parties.
• Conduct audit activities to identify adverse events and protocol violations.
• Provide procedural guidance to investigators for minor adverse events or violations.
• Conduct For-Cause Audits as requested by the Institutional Review Board Committee.
• Communicate For-Cause Audit findings to relevant parties.
• Maintain and update post-approval monitoring policies and procedures.
• Develop and provide post-approval monitoring education sessions for researchers.
• Engage with university and affiliate research departments to ensure compliance with federal regulations and institutional policies.

Benefits

• Competitive salary range of $47,866 - $57,441 per year.
• Full-time employment with regular hours.
• Opportunities for professional development and education.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Educational Services
• Education Level: Bachelor's degree