Rutgers, The State University of New Jersey, is seeking a Coordinator of Administrative Services for the Office for Research. As part of the Office for Research, this position is responsible for the review of the Human Subjects Protection Program (HSPP), creating educational modules and aiding key individuals with understanding and meeting AAHRPP standards. This position is responsible for the development and ongoing conduct of Association for the Accreditation of Human Research Protection Programs (AAHRPP) quality assurance program, summarizing findings and collaborating with others to effect improvements in all parts of the organization.
Among the key duties of this position are the following:
Serves as the subject matter expert in planning, coordinating, and managing the maintenance and adherence to the Institution's AAHRPP accreditation University-wide.
Develops and provides education to University leadership as well as the research community in relation to AAHRPP requirements.
Communicates accreditation and accreditation-related information to multiple departments.
Interprets accreditation and related (e.g., regulatory) rules or rule changes and serves as a subject matter human subjects protection expert for complex protocols; including protocols in both biomedical as well as social-behavioral disciplines
Assists with policy and guideline development, approval, dissemination, posting, archiving, and reporting, including researching and analyzing national best practices.
Collaborates with relevant departments, teams, and /or personnel to provide strategies, tools, and approaches to achieve and sustain compliance with accreditation standards.
Minimum Education and Experience:
Bachelors Degree or an equivalent combination of education and/or experience.
A minimum of two (2) years of related IRB regulatory experience or research administration experience.
Required Knowledge, Skills, and Abilities:
Knowledge of applicable federal regulations related to IRB and clinical/social research experience in research administration in support of clinical/social research and/or IRB experience in a health care environment.
Knowledge of FDA, HHS and ICH (E6) regulations and guidelines and AAHRPP Accreditation Standards is required, including working knowledge of AAHRPP standards and accreditation process.
Ability to research, review, accurately interpret, and communicate complex accreditation standards and related regulations and best practices.
Ability to communicate effectively both verbally and in writing.
Strong organizational skills, including accuracy and attention to detail.
Strong knowledge of office information technology.
Ability to meet deadlines and excellent time management skills.
Team player and ability to work effectively with staff and management.
Use of personal vehicle in order to travel for business demands; a valid driver's license would be required for this position.
Five (5) or more years in a research regulatory environment in human subjects' research, either on the research regulatory affairs side as an administrator or in a similar health-care setting.
Experience and knowledge related to IRB issues and human subjects research protection or equivalent combination of experience and education (typical experience might include ethics, clinical trial performance -industry or sponsor-investigator, and/or experience in an academic health center or medical school).
Microsoft Office Suite, electronic databases
Physical Demands and Work Environment:
Travel amongst campuses as needed.
Clean Driving Record
Posting Number: 21ST0750
Location: Rutgers University - New Brunswick
Internal Number: 129415
About Rutgers University
Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.