Clinical Research Associate

Overview New Jersey's academic health center, Rutgers Biomedical and Health Sciences (RBHS) takes an integrated approach to educating students, providing clinical care, and conducting research, all with the goal of improving human health. Aligned with Rutgers University-New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and five centers and institutes that focus on cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research. Our faculty are teachers, clinicians, and scientists with unparalleled experience who advance medical innovation and provide patient care informed by the latest research findings. We offer an outstanding education in medicine, dentistry, pharmacy, public health, nursing, biomedical research, and the full spectrum of allied health careers. Our clinical and academic facilities are located throughout the state-at Rutgers University-New Brunswick, including Piscataway; and at locations in Newark, Scotch Plains, Somerset, Stratford, and other locations. Clinical partners include Robert Wood Johnson University Hospital in New Brunswick, Newark's University Hospital in Newark, and other affiliates. Through this community of healers, scientists, and scholars, Rutgers is equipped as never before to transform lives. 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 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. 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. Required Knowledge, Skills, and Abilities Strong regulatory research specific knowledge (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. Benefits 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 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. 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. Immunization Requirements Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Additional infection control and safety policies may apply. Prospective employees should speak with their hiring manager to determine which policies apply to the role or position for which they are applying. Failure to provide proof of vaccination for any required vaccines or obtain a medical or religious exemption from the University will result in rescission of a candidate's offer of employment or disciplinary action up to and including termination. Equal Employment Opportunity Statement It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we encourage all qualified applicants to apply. For additional information please see the Non‑Discrimination Statement at the following web address: #J-18808-Ljbffr