Job Description

Position 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. 

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.  

City: New Brunswick

State: NJ

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. 

Posting Number: 25ST0217

About Rutgers University

Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.

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