University of Rochester Health Project Coord in Rochester, New York
Full Time 40 hours Grade 053 Ortho, Clinical Research
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 other staff.
Under the general direction and with some latitude for independent judgement for the direction and results of the research:
- Oversee and coordinate human subject research activities for single or multiple sites. Develop, implement, and evaluate recruitment strategies, information, and data systems, as well as study management systems. Participate in the planning, development, and implementation of study design, budgets, protocols, consent forms, process, and policies that may include multiple therapeutic areas. Participate in the development, review, and approval of case report forms (CRFs) and study-specific procedure manuals and documents.
- Represent 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 coordination of human subject studies. Responsible for supporting the contacts and relationships between and among the Principal Investigator, research staff, study sites, and sponsoring and regulatory agencies.
- Develop, implement, and monitor systems and methods to ensure consistency, efficiency, quality, and safety in the processing of human subject research data. Review study progress, including data, documentation, finances, and reporting deliverables. Design, develop, implement, and manage systems and procedures for the purpose of tracking study progression.
- Ensure compliance with all applicable regulatory and institutional requirements and standards. Ensure the integrity and security of all study data at all times. Initiate, monitor, and ensure that all protocol activities are standardized across study sites. Implement immediate and appropriate corrective action when inconsistency of activities is identified.
- Train research coordinators and other staff about activities associated with conducting human subject research specific to study protocols and compliance with Good Clinical Practice (GCP) guidelines and sponsor requirements.
- Direct the activities of subordinate and other relevant staff to gather, compile, and analyze study information.
- Coordinate and monitor financial data for budget and variance reporting, as well as for compliance with all institutional requirements for adequate system controls.
- Remain knowledgeable on current federal, state, sponsor, and institutional policies and laws, standard operating procedures, guidelines, as well as industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs, and implement and monitor resulting study changes. Demonstrate continuous professional development in accordance with Good Clinical Practice guidelines.
Bachelor’s degree and 2-3 years of experience in human subject research coordination; or an equivalent combination of education and experience. Professional Research Coordination Certification (e.g. SoCRA or ACRP) preferred. Experience as a Human Subject Research Coordinator I preferred.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Health Project Coord
Location: School of Medicine & Dentistry
Job ID: 202031
Full/Part Time: Full-Time