HRPP Compliance Analyst-Term

The VU HRPP (Human Research Protection Program) Compliance Analyst-Term is part of the Human Research Protections Program at Vanderbilt University and is a key individual contributor responsible for facilitating the ethical conduct of research with human subjects. This position will support operations of the universitys Institutional Review Board evaluate applications to ensure that the rights of human participants are protected and assist researchers with the IRB process. Reporting directly to the Director of the VU Human Research Protections Program the HRPP Compliance Analyst-Term will regularly engage with faculty staff and student researchers.

This is a fully remote role. This is a full-time term role.

The Vanderbilt University Human Research Protections Program (VU HRPP) is a new program that supports Vanderbilt University Social Behavioral and Educational Research (SBER) human subjects research. The HRPP Compliance Analyst is a vital member of this program and facilitates the research protocol review process from the initial submission to the study completion. As a knowledgeable and trusted expert the HRPP Compliance Analyst will provide SBER regulatory expertise to the IRB and research community to facilitate research in a manner that protects human research participants.

Research Integrity and Compliance (RIC) within the Office of the Vice Provost for Research and Innovation (OVPRI) oversees the VU Human Research Protections Export Compliance and Research Security programs. Additionally RIC coordinates with a network of offices and schools to help faculty students and staff meet regulatory legal and ethical obligations that accompany research.

The goal of the OVPRI is to promote Vanderbilts distinctive research culture which aspires to improve the human condition through path-breaking discovery and innovation. The office develops strategies and provides services to enhance extramural support for research and its application to significant challenges advance a cohesive and vibrant trans-institutional research agenda and build strategic partnerships around shared priorities.

NOTE: A Term position is a staff position that exists for a period longer than six months but is not expected to last beyond one year. Although a position may exist for a specified or indefinite period staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment either within the term or when the term ends.

Key Functions and Expected Performance:

• Interpret and apply federal and state laws regulations institutional policies and guidelines to protect human subjects and to ensure institutional compliance
• Collaborate with the university community to facilitate research
• Move submissions through the office workflow in a timely manner. This includes ensuring that submissions are review-ready prior to routing to the committee and conducting non-committee reviews such as expedited reviews exempt determinations study personnel changes and non-human subjects research determinations.
• Coordinate IRB activities including assigning reviewers drafting committee meeting agenda recording meeting minutes and ensuring that the record reflects review status
• Author and disseminate correspondence that conveys review results IRB deliberations and contingencies for approval of research activities
• Provide regulatory and ethical training and advice to faculty staff and students
• Maintain current working knowledge of the regulations and best practices for the protection of human subjects in research. This includes conducting research to prepare guidance and reports for the IRB on scientific ethical and regulatory topics.
• Support the VU HRPP Director with efforts to continually improve HRPP operations and increase program consistency. This includes assisting with the development of policies and procedures.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

Education and Certifications

• Bachelors degree in relevant academic field with a minimum of eight (8) years of directly related work experience is required
• Advanced degree in relevant academic field preferred
• At least 8 years of direct human subjects research protection/IRB regulatory experience reviewing and processing IRB submissions preferred
• Other combination of education and work experience that provides required knowledge skills and abilities deemed necessary for this position allowed
• Certified IRB Professional (CIP)/Certified IRB Manager (CIM) preferred

Experience and Skills:

• Expertise in the Code of Federal Regulations (including OHRP FDA HIPAA FERPA PPRA etc) NIH and NSF policies pertaining to human subjects research is preferred.
• Experience with multi-site studies including basic knowledge of the reliance processes
• Experience with studies conducted internationally
• Experience with IRB electronic systems and virtual meeting tools including Zoom Webex and Microsoft Teams
  • Knowledge of and experience with Huron software is preferred.
• Strong written and oral communication interpersonal and customer service skills are necessary.
• Detail-oriented with the ability to multi-task and prioritize workload.
• An ability to analyze complex scientific and ethical issues creativity in finding solutions and discretion in handling confidential and sensitive information.