Clinical Research Associate

Posting 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 Clinical Research Associate will serve as a member of a multidisciplinary research team, utilizing specialized knowledge in human subjects protection, regulatory guidance, and coordination with Institutional Review Board approval guidelines. The role ensures regulatory compliance in research protocols and organizes regulatory filings and communications with regulators and sponsors. Key Responsibilities Provide overall study regulatory coordination and protocol compliance per FDA, GCP guidelines, OHRP, HIPAA, Conflict of Interest, IRB, and institutional guidelines. Assist investigators and coordinators with development of IRB submissions, consent forms and other documents for regulatory review. Assist investigators and research staff in preparing regulatory and compliance documentation required for grant submissions, including human subjects sections and protocol summaries. Lead coordination and development of regulatory and compliance components for sponsor progress reports, including RPPR submissions, by tracking documentation, verifying status, and assembling materials. Organize development of protocol‑specific regulatory binders, manage sponsor communications, and maintain version control of protocols and ICFs. Education & Experience Master’s Degree in a related field plus three (3) years of research experience, two (2) of which included university‑level regulatory affairs. Required Knowledge, Skills, and Abilities Strong regulatory research knowledge base (IRB, informed consent, human subjects protection). Proficiency with Microsoft Office and research databases. Ability to maximize resources efficiently. Detail oriented with excellent organizational, communication, and interpersonal skills. Accountable to high standards of professional excellence. Preferred Qualifications Experience in a research university setting. Physical Demands Standing, sitting, walking, talking and hearing. No special vision requirements. Must lift or exert force up to 25 pounds. Work Environment Clinical and office environment. Working with patients. Benefits Medical, prescription drug, and dental coverage. Paid vacation, holidays, and various leave programs. Competitive retirement benefits, defined contribution plans and voluntary tax‑deferred savings options. Employee and dependent educational benefits (when applicable). Life insurance coverage. Employee discount programs. Salary Minimum: $68,147; Mid‑Range: $81,720; Maximum: $96,989. Work Schedule Full‑time position; standard hours 37.5 per week. Fully on‑site work arrangement; may be eligible for compressed workweek or flex workday schedule subject to approval. Immunization Requirement May be required to provide proof of Seasonal Influenza vaccination during Flu season. Failure to provide proof may result in rescission of offer or disciplinary action. Equal Employment Opportunity Rutgers University is an equal access/equal opportunity institution. All applicants and employees are considered equally under federal, state, and local laws. Non‑Discrimination Statement available at uhr.rutgers.edu/non-discrimination-statement. #J-18808-Ljbffr Rutgers University