Position Summary:

• Serves as primary point of contact with internal and external collaborators including the sponsor, clinical research organization, institutional review board, principal investigator and the study team. 
• Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, and PI or investigators. 
• Performs and manages multiple research and technical operations independently or as assigned (including preparing, compiling and coordinating regulatory document submission for pharmaceutical and clinical research organization, IRB correspondence, ensuring data quality by performing regular audits according to Standard Operating Procedures with high precision) followed by appropriate reports, recommendations and conclusions. 
•  Assists with the preparation of proposals, formal applications and justifications for grant applications. 
• Develops recommendations regarding budget proposals for the research projects and actively work with finance team to generate and reconcile invoices for study-related payments. Assists in the establishments of performance standards including regulatory compliance as well as to write and/or maintain standard operating procedures, department working practices ensuring FDA commitments are met and are as per standard medical practices from study start-up till close-out. 
• Assists with the instructing and training of clinical research coordinators, research assistants, and fellows to develop the skills necessary on adherence to compliance policies and procedures in research.

Minimum Education and Experience:

• Master's Degree in a relevant science plus two (2) years of related regulatory research experience, or a Bachelor's Degree in a relevant science plus three (3) years of related research experience required. 

City: New Brunswick

State: NJ

Physical Demands and Work Environment:

• Physical Demands: Attending meetings and regular computer use requires sitting and using hands to finger, handle or feel over 2/3 of the time. Due to the location of our clinical facilities, standing and walking can be expected up to 2/3 of the time. Typing and writing requires reaching with hands and arms up to 2/3 of the time. Lifting medical records, case report forms and laboratory supplies can require lifting up to 50 lbs. in addition to stooping, kneeling or crouching for such materials 1/3 of the time. 
• Work Environment: Office environment with moderate noise.

Posting Number: 25ST0512

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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