Rutgers, The State University of New Jersey is seeking a highly motivated Clinical Research Coordinator for the department of Medicine-Infectious Diseases within the New Jersey Medical School.
The Clinical Research Coordinator is responsible for coordinating activities of domestic and international research programs and will execute directly/delegate as appropriate duties.
Among the key duties of this position are the following:
Serves as a lead clinical coordinator for all industry and investigator sponsored international research, assuring compliance with applicable regulations. Serves as Rutgers and/or PI liaison with sponsor staff and collaborating site teams in protocol and regulatory affairs.
Work with Investigators in proposal development/writing, including collecting materials from sites for proposal development.
Travel to and works directly with domestic and international collaborating sites for short or extended stays. Study start up activities including investigator recruitment and election, collection of regulatory documents, site preparation and Site Initiation Visits.
Manage daily project management activities including team leadership, sponsor interactions, vendor management, project team performance and resource management.
Develops, implements and evaluates standard operating procedures (SOPs) for the clinical research program. Working in conjunction with investigators, site coordinator and any Rutgers dedicated coordinator, operationalizes the protocols for conduct.
Serves as a resource to division personnel and research program staff on these policies as it relates to international research.
Works with the regulatory coordinator to assure that regulatory files for international clinical research studies are maintained as required in accordance with applicable regulations and guidelines. Responsible for overseeing the program's clinical research quality assurance plan.
Develops, maintains, and evaluates standard operating procedures as they relate to the conduct of quality assurance audits, and adjusts procedures in accordance with sponsor mandates.
Works with Investigators and Data Coordinating Center Director to set professional goals and objectives for staff.
Minimum Education and Experience:
Bachelor's degree in Science-related field.
Five years of progressively responsible clinical research experience with Good Clinical Practices (GCP) conduct, field-based clinical studies in pulmonary tuberculosis.
Experience in quality assurance mandatory. Thorough working knowledge of regulatory requirements, and human subjects' protection conduct.
Required Knowledge, Skills, and Abilities:
Demonstrated managerial skills and experience in education and training as it pertains to clinical research.
Must have appropriate cultural sensitivity to work with diverse populations, and ability to work independently and make effective decisions, or seek advice when needed.
Excellent organizational and communication skills required.
Demonstrated computer skills with Microsoft Office components, REDCap Data Capture Platform, FreezerPro Specimen Repository Software, video conferencing platforms, and ability to maintain/manipulate databases for statistical analyses.
Master's in Science – MA, MPH.
Physical Demands and Work Environment:
Ability to travel independently on long international flights, and visit facilities/institutions/collaborators in developing country settings.
Posting Number: 20ST0915
Location: Newark (RBHS)
Internal Number: 114929
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.