University of Rochester Human Subject Res Coord II in Rochester, New York
Full Time 40 hours Grade 053 Medicine M&D-Infect; Dis Unit
8 AM-4:30 PM
Coordinates human subject research activities which may include multiple site human subject studies. May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. May supervise others.
Under general direction and with some latitude for independent judgment for the direction and results of the research:]
- Oversees and coordinates human subject research activities for single or multiple sites. Develops, implements and evaluates recruitment strategies, information and data systems, as well as study management systems. Participates in the planning, development and implementation of study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas. Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents.
- Represents sites, providers, study team, patients, study participants and the University to develop, monitor and maintain working relationships, positive communications and effective results with regard to the coordination of human subject studies. Responsible for supporting the contacts and relationships between and among Principal Investigator, research staff, study sites, sponsoring and regulatory agencies.
- Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Reviews study progress, including data, finances, documentation and reporting deliverables. Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression.
- Ensures compliance with all applicable regulatory and institutional requirements and standards. Ensures the integrity and security of all study data at all times. Initiates, monitors and ensures that all protocol activities are standardized across study sites. Implements immediate and appropriate corrective action when inconsistency of activities is identified.
- Trains research coordinators and other staff about activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.
- Directs the activities of subordinate staff and relevant others to gather, compile and analyze study information.
- Coordinates and monitors financial data for budget and variance reporting, and for compliance with all institutional requirements for adequate system controls.
- Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs, implements and monitors resulting study changes.
Bachelor's degree and 3 years of experience in human subject research coordination; or an equivalent combination of education and experience. Knowledge of word processing and data analysis software. Professional Research Coordinator Certification (i.e., SoCRA or ACRP) preferred. Experience as Human Subject Research Coordinator I preferred.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord II
Location: School of Medicine & Dentistry
Job ID: 211021
Full/Part Time: Full-Time