Research Associate (IRB Coordinator)

Temporary/Permanent:

Temporary

Duties and Responsibilities

(** Denotes Essential Functions)

• **Under the direction of the Human Studies Program Manager, conducts human subjects research application pre- reviews for completeness, accuracy, and appropriate level of review and continuous monitoring of human research projects in accordance with federal, state, university, and accrediting organization (AAHRPP) policies and procedures within a target timeframe.
• **Works with the Human Studies Program Manager, IRB members, other HSP personnel, and the research community to ensure regulatory compliance and ethical oversight of human subjects’ research by serving as a resource for ethical research practices and regulatory requirements.
• **Responsible for coordinating monthly Institutional Review Board (IRB) meetings, special meetings, and investigations, IRB reviews, develops meeting agendas, provides IRB members and research applicants with meeting notices and schedules applicant interviews, and writes meeting minutes and/or post-incident reports as required by federal regulation.
• **Serves as a liaison between the IRB and the research community, providing regulatory support and guidance while maintaining IRB member anonymity.
• **Serves as a regulatory subject matter expert in Biomedical and Social & Behavioral Sciences human subjects research.
• **Serves as an IRB member and engages in continuing education, maintaining required IRB member training.
• **Cultivates and maintains relationships with research community members, research teams, and administrators.
• **Reviews applications with regard to researcher and key personnel conflict of interest.
• **Remains aware of recent academic and scientific literature in the field and advises the IRB of such, coordinating scientific review of human subjects research applications.
• **Assesses special protections for vulnerable populations and determines and/or recommends to the IRB whether the special protections for vulnerable populations are adequate and in compliance with policies and procedures.
• **Supports the University through HSP local community outreach, training, and collaboration in educational programming as required by accreditation.
• **Assists the HSP Manager in reporting of Unanticipated Problems to university officials, the Office of Human Research Protections, and the Federal Drug Administration when appropriate.
• **As appointed by the IRB, reviews exempt applications and coordinates IRB member review of exempt applications, providing guidance and support.
• **Provide protocol status information, upon request, to the Office of Research Services to facilitate the processing of extramural awards that require IRB approval.
• **Prepares written standard operating procedures (SOPs) and assists in the implementation of policies to effect corrective action in problem areas as identified by IRB evaluation, post-approval monitoring, federal regulation and accreditation expectations.
• **Attends and participates in continuous education related to human subjects research.
• **Assists HSP Manager and IRB Chair in recruitment and training of new IRB members.
• **Facilitate IRB Authorization Agreements (IAAs) for ceding IRB oversight to and from other institutions.
• **Assist the HSP Manager in creating the outreach and educational curriculum of the UH Human Studies Program by maintaining current in depth knowledge of evolving IRB National & International standards (EU GDPR, for example), changes, protocols and processes in education and training, develop and implement HSR and Research Ethics educational programs and training for IRB members (train new members and regularly provide continuing education), HSP Personnel (continuing education), OVPRI Personnel, UH System research community (lectures, presentations, workshops, conferences, webinars, other educational resources), and collaborate with other organizations such as HIDOE, HIDOH, and Public Health, and other HSP personnel nationally such as PRIM&R, Smart IRB, and AAHRPP.
• Other duties as assigned.

Minimum Qualifications

Education and Professional Work Experience

• Possession of a baccalaureate degree in biomedical / social / behavioral / education research or behavioral sciences, biology, public health, social work, psychology, nursing or related field and 5 years of progressively responsible professional experience with responsibilities for monitoring and ensuring regulatory compliance and protection relative to human subjects; or any equivalent combination of education and/or professional work experience which provides the required education, knowledge, skills and abilities as indicated.

Knowledge, Skills and Abilities

• Considerable working knowledge of principles, practices and techniques in the area of human subject research and activities as demonstrated by the broad knowledge of the full range of pertinent standard and evolving concepts, principles and methodologies.
• Considerable working knowledge and understanding of applicable federal and state laws, rules, regulations and theories and systems associated with ethical research.
• Demonstrated ability to resolve wide ranging complex problems through the use of creative reasoning and logic to accurately determine the cause of the problems and the resolution of the problems in an effective, innovative and timely manner.
• Demonstrated ability to interpret and present information and ideas clearly and accurately in writing, verbally, and by preparation of reports and other materials.
• Demonstrated ability to establish and maintain effective working relationships with academic faculty and research personnel, university administrators, federal and state agencies, funding agencies, IRB committee members, accrediting organization administrators, and community members.
• Demonstrated ability to operate a personal computer and software, apply word processing software, data management, website, electronic filing, and online application software such as eProtocol.
• Must obtain a Valid Institutional Review Board (IRB) Professional (CIP) Certification at least two years from date of hire.
• Knowledge of the methods, procedures and techniques used in research or experimental laboratory work including research reporting and design both in biomedical and social and behavioral sciences research.

Desirable Qualifications

• Master’s or other advanced degree in biomedical or behavioral sciences, humanities, biology, public health, social work, psychology, nursing or related field.
• Work experience in a field where research typically included human subjects.
• Considerable knowledge of the principles of federal compliance.
• Training in the ethical protection of human subjects in research.