University of Rochester Clinical Research Coordinator - 225080 in Rochester, New York
Clinical Research Coordinator
School of Medicine & Dentistry
Full Time 40 hours Grade 051 Medicine M&D-Gastroentrol Div
8 AM-4:30 PM
With direction from the Human Subject Research Coordinator II (HSRC II) and Senior Research Coordinator (HSRC III) coordinates human subject research activities within the Division of Gastroenterology and Hepatology The HSRC I is expected to 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.
Assigned Research Protocols/Studies
Oversees and coordinates human subject research activities for single or multiple trials
Participates in the development, implements and evaluation of:
Study design, procedure manuals, consent forms and case report forms
Data systems for tracking study progression, monitor and report on deliverables, quality and safety tracking
Represents sites, providers, study team, patients, study participants and the University 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
Ensures compliance with all applicable regulatory and institutional requirements and standards
Ensures the integrity and security of all study data at all times
Training and Oversight
Assist with training on specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.
Monitors for compliance with all institutional requirements for adequate system controls
Other Duties as Assigned
Assist as needed with projects and programs that support the mission of the division, research department and members of the research team
May include travel for study specific training
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.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled