Clinical Research Associate

Clinical Research Associate

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.

FLSA - Exempt Grade - 24S Salary Details Minimum Salary - 68147.000 Mid Range Salary - 81720.000 Maximum Salary - 96989.000 Offer Information - The final salary offer may be determined by several factors, including, but not limited to, the candidate's qualifications, experience, and expertise, and availability of department or grant funds to support the position. We also take into consideration market benchmarks, if and when appropriate, and internal equity to ensure fair compensation relative to the university's broader compensation structure. We are committed to offering competitive and flexible compensation packages to attract and retain top talent.

Benefits - Rutgers provides a comprehensive benefits package to eligible employees. The specific benefits vary based on the position and may include: Medical, prescription drug, and dental coverage Paid vacation, holidays, and various leave programs Competitive retirement benefits, including defined contribution plans and voluntary tax-deferred savings options Employee and dependent educational benefits (when applicable) Life insurance coverage Employee discount programs

Position Status - Full Time Working Hours Standard Hours - 37.50 Daily Work Shift Work Arrangement - Consistent with the current application of Rutgers Policy 60.3.22 or the applicable provisions of relevant collective negotiations agreements, this position requires a fully on-site work arrangement and may be eligible for a compressed workweek or a flex workday schedule. Flexible work arrangements are not permanent, are subject to change or discontinuation, and contingent on the employee receiving approval in the View email address on click.appcast.io Application System.

Union Description - HPAE 5094 Payroll Designation - PeopleSoft Seniority Unit Terms of Appointment - Staff - 12 month Position Pension Eligibility - ABP

Qualifications 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. Certifications/Licenses 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. Must hold self accountable to high standards of professional excellent.

Preferred Qualifications - Preferred experience in a research university setting. Equipment Utilized 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.