University of Rochester Health Project Coord - 225408 in Rochester, New York
Health Project Coord Job ID 225408
School of Medicine & Dentistry
Full/Part Time Part-TimeFavorite Job
Part Time 20 hours Grade 053 Pediatric Nephrology
8:00 AM - 12:00 PM
Health Project Coordinator will assist the Division of Pediatric Nephrology in our site participation in collaborative research consortia in pediatric nephrology and in quality initiatives in pediatric dialysis. Study coordinator must be organized, hard-working, culturally sensitive, able to work as a team member as well as independently, excellent communication skills, able to prioritize tasks, and comfortable handling confidential information. Keeps up-to-date with current federal regulations for conducting clinical studies. Keeps current with industry standards and therapeutic areas relevant to sponsored studies.
NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.
Conducts patient recruitment and screening through flyers, advertisements and pediatrician offices. Screens for potential study candidates that meet the proposed protocol criteria. May assist in developing recruitment strategies and targets.
Attends subject visits at the Clinical Research Center, gathering data specific and meets with subjects as needed under the direction of the PI.
Assists with data collection, management, analysis, interpretation, and reporting which includes assisting with manuscript, poster, and abstract preparation as well as for publication or grant requests or the like and data base management.
Ensures compliance with acceptable regulatory requirements and IRB standards. Ensures integrity of all study data collected. Ensures protocol activities are administered consistently across studies. Serves as liaison between PI, research sites and sponsoring and governmental agencies. Prepares materials for and corresponds with IRB:
Corresponds with IRB about study related issues and general inquiries.
Independently fills out and submits applications for IRB approval
Organizes study related information (enrollment, follow-up, findings, etc.) and submits these annual progress reports to IRB.
Submits amendments to IRB when a change in protocol or survey is needed.
Reports all adverse events in timely fashion to IRB
Relates information between investigator and IRB
Generate reports both for the IRB and grant funders.
Assists with planning, development and implementation of study designs, budgets, data collection tools, protocols, and consents for multiple site clinical trials across various therapeutic areas according to regulatory requirements. Tracks study documents. Coordinates expenditure controls.
Prepares, maintains and reviews study charts to insure protocols are followed in compliance with established regulations.
Provides professional direction within the project. Maintains a working knowledge of the area(s) of expertise by reviewing research literature and abstracts, attending pertinent meetings and seminars.
Performs other similar duties as assigned by Senior Health Project Coordinator and principle investigator, including acting as back up for the Senior Health Project Coordinator.
Bachelor’s degree with major course work in an appropriate health, social or technical field, two to three years of related experience; or an equivalent combination of education and experience.
Competencies: Requires at least 1 year of clinical research experience, including knowledge of data collection and data management. Familiarity with Microsoft, including Excel, and basic understanding or familiarity with database use and maintenance is helpful. Experience with the University online RSRB application system preferable.
Hours: Part Time (20 hours per week). Flexible weekday, daytime hours. No evenings or holidays. Schedule may vary based on operational needs
Reports to: Division Chief
Supervisory responsibilities: None
Equipment: Telephone, computer, printer, scanner, copier, fax, label printer and multifunction device. Employee will use software for grants and documentation and other systems as needed.
Training / Certification Expectations: CITI
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled