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Compliance Analyst, Human Research Protections Program
4 months ago
Compliance Analyst, Human Research Protections Program
Nashville, TN, United States
JOB DESCRIPTION
The VU HRPP Compliance Analyst 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 university's 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 will regularly engage with faculty, staff, and student researchers.
The Vanderbilt University Human Research Protections Program (VU HRPP) is a new program that will support Vanderbilt University Social, Behavioral and Educational Research (SBER) human subjects research. The HRPP Compliance Analyst will be a vital member of this new program and will facilitate 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, the Export Compliance, and the 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 Vanderbilt's 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.
Duties and Responsibilities
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.
Qualifications
Bachelor's degree in relevant academic field with a minimum of two (2) years of directly related work experience is required.
Other combination of education and work experience that provides required knowledge, skills, and abilities deemed necessary for this position allowed.
Advanced degree in relevant academic field, preferred.
Certified IRB Professional (CIP)/Certified IRB Manager (CIM), preferred.
At least 2 years of direct human subjects research protection/IRB regulatory experience reviewing and processing IRB submissions is preferred.
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 Team.
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.
Commitment to Equity, Diversity, and Inclusion
At Vanderbilt University, we are intentional about and assume accountability for fostering advancement and respect for equity, diversity, and inclusion for all students, faculty, and staff. Our commitment to diversity makes us who we are. We have created a community that celebrates differences and lets individuality thrive. As part of this commitment, we actively value diversity in our workplace and learning environments as we seek to take advantage of the rich backgrounds and abilities of everyone. The diverse voices of Vanderbilt represent an invaluable resource for the University in its efforts to fulfill its mission and strive to be an example of excellence in higher education.
Vanderbilt University is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran, or any other characteristic protected by law.
Please note, all candidates selected for an offer of employment are subject to pre-employment background checks, which may include but are not limited to, based on the role for which they have been selected: criminal history, education verification, social media review, motor vehicle records, credit history, and professional license verification.
