Human Subjects Protection (HSP) Specialist

Human Subjects Protection Specialist

The Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) is a clinical trials network funded by the National Institute for Neurological Disorders and Stroke (NINDS) and the National Heart Lung and Blood Institute (NHLBI). The Clinical Coordinating Center for SIREN resides within the Department of Emergency Medicine at the University of Michigan.

SIREN is seeking a Human Subjects Protection (HSP) Specialist to lead ethical oversight for our high-impact, multi-center network. With 60+ performance sites nationwide, SIREN identifies life-saving treatments for neurologic, cardiac, respiratory, and trauma emergencies.

Because our research often occurs when patients cannot provide consent, as our HSP Specialist, you will become the primary coordinator of our processes related to exception from informed consent for emergency research (EFIC) as per 21 CFR 50.24. You will become a national expert on EFIC, ensuring our performance sites maintain the highest standards of ethics, transparency, and community trust.

Responsibilities*

• EFIC Program Management and Oversight (40%)

  • Subject Matter Expert: Serve as a national leader on 21 CFR 50.24 requirements.

  • Lifecycle Management: Oversee EFIC plans from inception to closeout, ensuring every site meets rigorous Community Consultation (CC) and Public Disclosure (PD) milestones.
  • Regulatory Reporting: Draft and review EFIC-related content for FDA Dockets, Cumulative reports for Scheduled Continuing Reviews of IRB approvals, NIH Research Performance Progress Reports (RPPR), and new grant proposals.
  • Data Integrity: Audit EFIC reporting and eConsent captures within WebDCU and REDCap to ensure "audit-ready" documentation at all times.

• Strategic Liaison & Network Collaboration (40%)

  • Primary Point of Contact: With our single IRB (Advarra), centralized EFIC vendor, site Principal Investigators and site Study Coordinators.
  • Working Group Leadership: Facilitate the HSP and EFIC IRB Collaborative working groups, driving consensus and policy updates across the network.
  • Communications Partner: Collaborate with the SIREN Education Coordinator to create community outreach materials and training in consenting skills.

• Process Innovation & Training (10%)

  • Systems Design: Design and implement scalable workflows, tools, and training modules to enhance site-level EFIC activities.
  • Technical Lead: Serve as the REDCap subject matter expert for eConsent builds and troubleshooting.
  • Mentorship: Provide ongoing mentorship and feedback to site personnel to ensure continuity of study operations from startup to closeout.

• Academic & Professional Impact (10%)

  • Dissemination: Represent SIREN at national forums and professional meetings, presenting findings on HSP best practices and EFIC implementation.
  • Continuous Improvement: Identify and implement scalable operational efficiencies that support human subjects' protection across the entire SIREN portfolio.

Required Qualifications*

• Bachelor's degree in public health, clinical research, or a related field.
• Minimum of 5 years of progressive clinical trial experience, specifically within a multi-center or regulatory framework.
• Proficiency in REDCap and familiarity with electronic data capture (EDC) systems.
• Deep understanding of ICH-GCP, FDA regulations, and the ethical nuances of human participant research.
• Proven ability to lead cross-functional teams and optimize complex workflows.
• Willingness to travel by airplane (1-2 trips lasting 2-3 days annually possible).

Desired Qualifications*

• Master's level degree in public health or a related field.
• Prior experience specifically with 21 CFR 50.24 (EFIC) protocols.
• Professional certification (e.g., CCRP, CCRC, or CIP).
• Ability to work in a hybrid work mode with 2 or more days in the office per week

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Additional Information

Work Locations

The SIREN CCC operates as a hybrid workplace . While the primary office is located at Domino's Farms in Ann Arbor, we offer flexible scheduling and remote opportunities based on program needs.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an equal employment opportunity employer.