IRB Analyst/Human Participants Protections Specialist

MPHI is a Michigan-based and nationally engaged, non-profit public health institute. We are a team of teams, process and content experts, dedicated to building A world where tomorrow is healthier than today!

Title: IRB Analyst/Human Participants Protections Specialist

$53,000 - $70,000 / Posted Thru: 2-20-25

Location: Remote/Virtual

Purpose: Under general supervision of the Director of Research Integrity & Compliance, the Analyst/Specialist supports and oversees a wide range of activities required to manage research integrity and organizational compliance related to MPHI project work in compliance with Federal and State regulations and Institute policy. A broad knowledge of research and privacy regulations and ethical considerations for human participant engagement in research and non-regulated research activity, as well as an in-depth knowledge of Institutional Review Boards (IRB) and social, behavioral, educational (SBER) evaluation and public health research and non-research activities, is needed to be successful in this position.

• Assist with evaluation of exempt and expedited research protocol submissions and non-research determinations
• Participate in research reviews, serving on MPHI's IRB.
• Conduct ethical reviews of non-research human participant engagement.
• Participate in federal and internal audits and inspections as pertain to MPHI's Federal-wide Assurance (FWA), Institutional Review Board (IRB) and Office of Research Integrity & Compliance (ORIC).
• Serve as a liaison and resource to MPHI staff, IRB members, Privacy Officer/Specialist, Security Officer, Risk Manager and Research Integrity Officer; interpret and relay sensitive and/or confidential information as appropriate.
• Help ensure compliance with regulations, policies, and laws that govern research activities related to human subjects, conflict of interest, and ethics.
• Assist with developing, implementing, and maintaining standard operating procedures for research, human participant protections, and the Electronic Project Library (EPL).
• Serve as an in-house advisor to MPHI employees and agents on regulatory, industry best practices, and other matters relating to human subject research compliance, providing ongoing consultation, technical assistance, and training.
• Help to develop and implement regulatory research education and training for all involved in research and research compliance, including researchers and research staff, IRB members and ORIC staff.
• Maintain cognizance of all federal, state, MPHI and funder regulations, laws, policies, and procedures that presently exist for research compliance and engagement of participants in non-research activities; assist with developing and maintaining systems for adherence to current and emerging guidelines, assuring that policies and procedures are revised and appropriately implemented.
• Review and monitor (Electronic Project Library) EPL records for completeness and consistency to assist programs in remaining compliant across project commitments and requirements and ensure MPHI establishes and maintains a state of audit readiness.
• Assist with various efforts to develop and define MPHI's human participants protection program; contribute to compliance efforts to assess and mitigate research and human participant engagement risk.
• Maintain and ensure thorough and comprehensive documentation of review activity and determinations.
• Apply knowledge of pertinent laws, regulations, policies, and procedures that affect human subject research protections and privacy.
• Assist in ensuring that all MPHI agents involved in human subject research are educated in policies and procedures governing such research.
• Develop and disseminate written communications to inform investigators and partners of stipulations required by the IRB/Privacy/Data Request approval of a protocol.
• Provide input on the development and updating of protocols.
• Work in partnership with the PIs, project team, and funding agency regarding project plans and problem-solving.
• Provide consultation and technical assistance to partners to ensure timely compliance with IRB and other Data Access/Use requirements; facilitate consistency and project integration.
• Assist with Single IRB and IRB reliance compliance.
• Assist with Data Request assessment and monitoring.
• Establish and maintain effective relationships with government and university officials and faculty, foundation agency personnel, and a variety of others under varied conditions; and, within guidelines, make independent judgments or decisions in taking the initiative to influence events in the best interest of MPHI.
• Maintain a positive, strong, credible, professional, and interpersonal relationship with all parties relevant to MPHI and represent the best interests of MPHI at all times.
• Attend conferences and seminars and participate in other self-initiated development activities in order to remain current in the field and with technology and software provided to support position functioning
• Perform other duties as assigned.
• Always represent the best interests of MPHI.

Experience: A minimum of 3 years related experience in an IRB or HRPP program conducting human subject research compliance review; experience developing processes and procedures for ensuring and demonstrating compliance is preferred. Experience in conducting community-based or community-engaged evaluations or public health activities with a strong understanding of ethical implications would be considered.

Important Skills and Characteristics:

• Strong organizational, problem-solving, and professional/diplomatic communication skills; excellent oral and written communication skills.
• Strong interpersonal and small group interaction capabilities.
• Self-directed, able to set priorities and attend to multiple tasks with minimal supervision.
• Flexible and analytic thinker.
• Ability to balance multiple priorities.
• Must be comfortable functioning in a fast-paced, changing, team environment.
• Familiarity with federal regulations, state laws, and MPHI policy concerning human subject research, consent/assent, participant privacy, and use of individually identifiable information.
• Knowledge of research methods.
• Proficiency in technical writing.
• Basic project management.
• Adept at using Microsoft Office applications, including Word, Excel, SharePoint, Teams, Adobe Pro, and Outlook.
• Willingness to learn and adapt to the use of novel or unfamiliar technologies necessary for or provided to enhance job performance.

Work Environment and Physical Requirements: Standard office environment. May require moderate physical effort, including lifting materials and equipment of <35#, and involve viewing CRT or VDT screen >75% of the time. May require limited occasional travel necessitated by participation in off-site functions. May require valid vehicle operator's license where needed to perform the duties of the position.

IMPACT ON PROJECTS, SERVICES AND OPERATIONS: This position has a direct impact on the quality of services provided by MPHI. Competent performance in this position has a substantial impact on the integrity and professional reputation of MPHI, including meeting the needs of MPHI clients in a timely manner, maintaining professional relationships, enhancing the potential for future contracts with clients, contributing to appropriate standards of operation in human subject protection for a non-profit research institute, and enhancing the skill set and expertise of Institute employees. Competence also ensures that current projects continue growing and maintain excellent client relationships.

For purposes of employment standards, this classification is "Exempt" from overtime provisions of the fair Labor Standards Act.

MPHI works with you to promote health for everyone. Together, we will build a world where tomorrow is healthier than today!

MPHI is an EEO/AA employer that participates with e-verify.