University of Rochester Human Subject Res Coord I - 219761 in Rochester, New York
Human Subject Res Coord I
School of Medicine & Dentistry
Full Time 40 hours Grade 051 Neurology - MC Admin M&D
8 AM-4:30 PM
Coordinates all aspects of assigned research studies associated with human subject research. Provides assistance to the Principal Investigator and works as an integral part of the study team.
Recruits, schedules, and conducts subject visits for research studies in accordance with study protocols, coordinating these visits with the Principal Investigator. May perform activities including but not limited to participant consent, vital signs, cognitive assessments, or mobility tests, as required by protocol. Works with ancillary service departments to schedule drug dispensing, lab assessments, and/or study imaging. Resolves questions and concerns received from study subjects, triaging to the Principal Investigator as necessary.
Understands and provides training on protocols, procedures, documentation, and use of study materials to subjects and team members as appropriate. Ensures compliance, follows up and communicates as needed. Keeps current with study-specific training.
Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolves issues (e.g., resolve queries from research visits), and enhance collaboration. Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol. Represents the University and Principle Investigator at study meetings as needed.
Manages the regulatory details for assigned research studies. Prepares and maintains regulatory and study documentation. Manages and submits amendments and continuing reviews for IRB approval. Ensures all regulatory requirements are met and documented.
Develops and/or manages databases for research studies. Ensures data is entered in a timely manner and database(s) is up-to-date.
Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and institutional policies and laws, industry standards and best practices, and trends in relevant therapeutic areas.
Bachelor’s degree and 1 year of experience in human subject research coordination; or equivalent combination of education and experience. Knowledge of word processing and data analysis software preferred.
Knowledge of word processing, spreadsheets, and electronic data capture (EDC) software preferred. Must have excellent communication skills.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled