Clinical Research Associate

Position Summary

Rutgers, The State University of New Jersey, is seeking a Clinical Research Associate in the Department of Medicine within the New Jersey Medical School (NJMS).

The primary purpose of the Clinical Research Associate position is to serve 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. Works with study coordinators in ensuring regulatory compliance in research protocols. Organizes and coordinates all regulatory filings and communications with regulators and sponsors.

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.
• 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.

Physical Demands and Work Environment

PHYSICAL DEMANDS:

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

WORK ENVIRONMENT:

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