Rutgers, the State University of New Jersey is seeking a highly motivated Clinical Research Coordinator for the department of Medicine- Infectious Diseases at 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 that include: Interacting with collaborating sites domestically and internationally to develop and ensure adherence to study protocols and compliance with study procedures; develop relationships with trial/study site investigators, research coordinators and other trial/study site personnel to assess study progress and identify potential obstacles to enrollment and meeting project milestones; support the Research Program and Investigators in their task to execute research and projects through project management, organization of meetings, coordination of tasks, subject recruitment, troubleshooting and intervention development, dissemination of documentation and information, and assistance with grant applications, research presentations and manuscript preparations/submissions. The Clinical Research Coordinator serves under the direction of the Director of Research Innovation and the Director of the Data/Operations Coordinating Center and Assists with supervision and mentoring of clinical research staff – study coordinators, student interns and other related staff.
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. Prepares required progress reports and analyses reflecting study progress, enrollment trends and implements recommendations and conclusions for all levels of project oversight, including the investigators, PI and Sponsor. Facilitates sponsor monitoring visits to Rutgers site or collaborating partner sites.
Works with Investigators in proposal development/writing, including collecting materials from sites for proposal development.
Assists in site selection, review of facilities, and preparation for collaborative projects, including conducting Needs Assessments and site evaluations of current and potential collaborating sites.
Travels to and works directly with domestic and international collaborating sites for short or extended stays. Study start up activities including investigator recruitment and selection, collection of regulatory documents, site preparation and Site Initiation Visits.
Trains the site staff on the protocol and amendments, adherence to specimen collection, labeling and shipping procedures. Functions as a resource for trial sites for all study-related issues, including site-related problem identification and corrective/ preventive solution development. Ensures that the research site meets all study related goals including accrual and retention of study participants. Maintains regular communication with site investigators and staff, reviews progress, identifies and implements solutions.
Manages daily project management activities including team leadership, sponsor interactions, vendor management, project team performance and resource management. Oversees the implementation of clinical research studies at the clinical sites, affiliated facilities and at the Data Coordinating Center. Manages data collection process in conjunction with DCC leadership team and coordinating staff, including with process of ensuring site compliance and patient data integrity. Directly supervise activities of Research Staff (Coordinators and student interns), including performance evaluations, and relays program and project specific information to staff, provides administrative and programmatic support to project staff and research coordinators.
Develops, implements and evaluates standard operating procedures (SOPs) for the clinical research program.
Maintains a current knowledge and general understanding of Newark campus Institutional Review Board (IRB) policies and procedures, and works with others to ensure research program activities are in compliance with such. Serves as a resource for 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. Directs and assists regulatory coordinator with writing IRB applications, including informed consent forms, continuing renewal requests and modification requests. Ensures the reporting of adverse events to the sponsor and to the IRB (Rutgers and collaborating sites) by regulatory coordinator and/or protocol specific study coordinator; assists with tracking adverse events for the purposes of annual reporting.
Maintains a current knowledge and understanding of Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations as they pertain to clinical research. Maintains an understanding of Good Clinical Practice (GCP) guidelines as well as other applicable international guidelines and regulations as they pertain to the countries where division research is conducted. Ensures that research program activities are in compliance with all applicable guidelines and regulations. Ensures training of site personnel in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and project specific Clinical Quality Management Practices. Provides re-training to staff on GCP, data collection and source documentation guidelines as needed.
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. Conducts chart audits, or oversees the conduct of chart audits, as per SOP. Maintains documentation of all quality assurance activities, provides staff with relevant and constructive feedback on salient findings Confirms investigative sites’ adherence to pertinent regulations with regard to protection of subjects’ rights and safety through development and/or review of monitoring reports, QA-GCP audit reports and communications with CRAs, and/or investigative site personnel issues.
Works with Investigators and Data Coordinating Center Director to set professional goals and objectives for staff. Provides direction and mentoring to staff, and assists them in meeting their goals. Establishes educational priorities for clinical research staff. Assures that all staff members attend relevant continuing education opportunities and encourages professional development.
Works on manuscript preparation, and assists in preparing data for analysis and publication in collaboration with investigators. Assists with preparation and presentation of study-related material at local, regional, national and international meetings and conferences in collaboration with PI and other investigators.
Minimum Education and Experience:
Bachelor's degree in Science-related field.
At least five years of progressively responsible clinical research experience with federally-sponsored work, the majority of which must be in international/global health in infectious diseases research.
Experience with Good Clinical Practices (GCP) conduct, field-based clinical studies in pulmonary tuberculosis.
Experience in quality assurance mandatory.
Required Knowledge, Skills, and Abilities:
Thorough working knowledge of regulatory requirements, and human subjects' protection conduct.
Demonstrated managerial skills and experience in education and training as it pertains to clinical research essential.
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 (concentration in Infectious Diseases; Epidemiology; Global Health; Clinical Research) preferred.
Ability to travel independently on long international flights, and visit facilities/institutions/collaborators in developing country settings.
Posting Number: 19ST2195
Location: Newark (RBHS)
Internal Number: 89534
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.