Position Summary:

• Provides overall study regulatory coordination and protocol compliance per FDA, GCP guidelines, OHRP, HIPAA, Conflict of Interest, IRB and institutional guidelines, and standard operating procedures set forth by Rutgers, the Division and Study Sponsor(s).
• Assists investigators and coordinators with development of IRB submissions, consent forms and other documents for review by regulatory officials/offices.
• Assists investigators and research staff in preparation of regulatory and compliance documentation required for grant submissions, including human subjects sections, protocol summaries, and supporting materials to ensure alignment with sponsor and institutional requirements.
• Leads coordination and development of regulatory and compliance components for sponsor progress reports, including RPPR submissions, by tracking required documentation, verifying regulatory status, and assembling materials in collaboration with investigators and research staff..
• Organizes the development of protocol-specific regulatory binders, communications with sponsor representatives and collaborator regulatory communications, protocol and ICF version control.

Minimum Education and Experience:

• Master's Degree in a related field plus three (3) years of research experience, two (2) of which shall have included university level regulatory affairs.

City: Newark

State: NJ

Physical Demands and Work Environment:

• Standing, sitting, walking, talking and hearing.
• No special vision requirements.
• Must be able to lift or exert force up to twenty-five (25) pounds.

• Clinical and office environment.
• Moderate noise.
• Working with patients.

Posting Number: 26ST0601

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.

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