University of Rochester Human Subject Res Coord I in Rochester, New York
Full Time 40 hours Grade 051 Surgery Research
Coordinates the activities associated with human subject research.
Under general direction within policy guidelines and approved procedures and protocols:
Coordinates the administrative details required to initiate and conduct human subject research, such as, receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials (i.e., brochures, advertisements, newsletters, etc.) to immediate team members and relevant others.
Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews patient medical chart history to verify inclusion criteria are met before enrollment.
Conducts visits to ensure research participant adherence with protocol requirements such as taking of medications, proper use of device, and/or other interventional activities; to document adverse events and report to senior study staff, Principal Investigator (PI), Institutional Review Board (IRB), Sponsor and/or any other required recipients or entities; and to ensure all data are collected and secured within approved parameters and procedures.
Attend surgeries and/or biopsies to collect tissue, blood and urine. After collection you will transport specimens to pathology and arrange tissue per tumor biobank SOP. A basic understanding of anatomy and pathology is a plus. Excellent attention to detail, and flexibility in work schedule desirable.
Acts as liaison with Sponsor’s Monitor: to provide data clarifications, to review study protocols, to ensure thorough understanding and communication, to respond to questions that arise during the study, to communicate and document adverse events as advised by the Principal Investigator, and to ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate and available for review. Communicates with Sponsor to clarify data queries to determine report format. Prepares for, participates in and serves as liaison for scheduled Sponsor monitoring visits (i.e., pre-study inspection, initiation, on-going and close out visits).
Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines, and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keeps current with industry standards, best practices, trends in therapeutic areas relevant to research studies; makes recommendations and implements changes as appropriate.
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.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord I
Location: School of Medicine & Dentistry
Job ID: 208195
Full/Part Time: Full-Time