Clinical Research Associate

Position Details

Position Information

Department RWJ-Cardiac Surgery

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.

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 for the Department of Surgery, Division of Cardiothoracic Surgery at the Robert Wood Johnson Medical School.The primary purpose of the Clinical Research Associate position is to serve as a member of a multidisciplinary research team and collaborate with the Principal Investigator and Sub-Investigators in coordinating all aspects of clinical research studies. Utilizes specialized knowledge, skills, and competencies in the sciences and/or patient management not limited to: patient screening and recruitment, protocol implementation; data collection and query resolution; device and drug accountability; submission to the Institutional Review Board (IRB); facilitation of clinical trial agreement execution; assistance with account management of research funds and budget reviews; correspondence with study sponsors and federal regulatory agencies for research; document preparation for site audits; and other related administrative and clerical tasks, as assigned. Follows patients enrolled in research protocols based on needs assessments. Plans and coordinates the care of patients in collaborations with all professional components of the Division.Among the key duties of this position are the following:

• Coordinates the functions, activities, and resources of the Division's clinical research. Maintains communication with PI and sub-investigators, patients, internal and external collaborators (e.g. consulting physicians), sponsors, federal regulatory agencies, and other involved parties as required.
• Provides overall study coordination and ensures protocol compliance per FDA, GCP guidelines, OHRP, HIPAA, IRB and institutional guidelines, and standard operating procedures.
• Develops and implements procedures to identify and recruit eligible patients for IRB approved studies.
• Ensures study parameters are correctly applied and eligibility criteria are met.
• Coordinates and participates in the analysis of study data. Responsible for the extrapolation, collection, compilation, and submission of data. This includes, but is not limited to patient registration, treatment plans, adverse event documentation and reporting, clinical response, and long-term follow-up for all services. Administers tests and collects data during study visits as needed. Appropriately assists with screening patients for study participation e.g. reviews medical records, collaborates with medical & research staff, etc.
• Organizes the development of study files, data management procedures, and logs. Maintains accurate and/or thorough documentation on all source documents and case report forms (CRFs) for each study patient, resolving all patient queries, reporting adverse events.

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/hospital level clinical monitoring.

• 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.
• Must have working knowledge of Microsoft Office products (Word, Excel, etc.).
• Solid knowledge of computer software programs (Microsoft Office, databases, etc.).

Preferred Qualifications - Experience in a hospital/university/healthcare institution.

Physical Demands and Work Environment - Physical Demands: Working at a computer, walking, standing, taking elevators or stairs.

• Work Environment: Hazards include risk of exposure to communicable diseases and operation of equipment. Potential exposure to Category I risks (blood/body fluid, biological agents) and hazardous chemicals.

Special Conditions

Posting Details

Location Details

Pre-employment Screenings

All offers of employment are contingent upon successful completion of all pre-employment screenings.

Immunization Requirements

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.

Affirmative Action/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, p regnancy, 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.

For additional information please see the Non-Discrimination Statement at the following web address: http://uhr.rutgers.edu/non-discrimination-statement