Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Rutgers, the State University of New Jersey is seeking a motivated Clinical Research Coordinator Supervisor for the Department of Medicine within the New Jersey Medical School. The CRC supports, facilitates and coordinates the daily clinical trial program activities, supervises clinical research staff, and plays a critical role in the conduct of the studies within the Division. By performing these duties, the CRC works with the Division Director, PI's, Division research staff, Department, Sponsor, and University to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies under the Division's clinical trial program.
Among the key duties of this position are the following:
Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and University and sponsoring agency policies and procedures.
Supervises and manages the Division of Gastroenterology and Hepatology Clinical Research Program and clinical research staff, including research coordinators, data entry clerk, patient navigator and other clinical research staff.
Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
Assists Principal Investigator to ensure that all key personnel or persons 'engaged' in the research projects have met training requirements in accordance with federal regulations and University and sponsoring agency policies and procedures.
Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
Cooperates with University and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
Collaborates with the PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.
Collaborates with the PI to prepare IRB and any other regulatory submission documents as required by the protocol.
Prepares study materials, as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
Reviews and develops a familiarity with the contract or award terms and conditions. Works with the PI to ensure that the study is in compliance with all terms and conditions, including but not limited to education, IRB approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.
Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
Minimum Education and Experience:
Bachelor's Degree in Healthcare, Healthcare Administration, or other related Healthcare field.
Minimum 5 years Clinical Research Coordinator experience.
Clinical Research Staff Supervisory experience.
Required Knowledge, Skills, and Abilities:
Minimum of 3 years in a Clinical Research Supervisory role.
Physical Demands and Work Environment:
Salary: Maximum authorized hiring amount $85,895
Posting Number: 19ST4366
Location: Newark (RBHS)
Internal Number: 102925
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.