Research - Laboratory/Non-Laboratory, Staff/Administrative
Rutgers, the State University of New Jersey is seeking a motivated Clinical Research Associate for the Department of Medicine-Infectious Diseases within the New Jersey Medical School.
The Clinical Research Associate serves as a member of a multidisciplinary research team, utilizing specialized knowledge, skills, and competencies in human subjects protection, regulatory guidance and coordination with Institutional Review Board approval guidelines.
Among the key duties of this position are the following:
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.
Organizes the development of protocol-specific regulatory binders, communications with sponsor representatives and collaborator of regulatory communications, protocol and ICF version control.
Maintains computer databases, as required, for tracking study regulatory communications, work flow processes and deadlines lists.
Acts as a liaison for division research studies with external and internal offices.
Monitors collaborator regulatory communications and site team compliance with human subjects protection regulations.
Maintains a high standard of professional responsibility and performance, participating in research and performance improvement activities.
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.
Required Knowledge, Skills, and Abilities:
Strong regulatory research specific knowledge base (IRB, informed consent, human subjects protection).
Solid knowledge of computer software programs (Microsoft Office, databases, etc.).
Demonstrated ability to maximize resources on a continued basis.
Must be detail oriented.
Must have excellent organization, communication, and interpersonal skills.
Experience in a research university setting.
Salary: 60503- 86109
Posting Number: 20ST0393
Location: Newark (RBHS)
Internal Number: 111076
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.