University of Rochester Clinical Research Assoc (S) in Rochester, New York
Full Time 40 hours Grade 053 Neuro-Ctr Human Exp Ther/CTCC
8 AM-5 PM; OCC WKENDS
The responsibility of the Clinical Project Coordinator, Associate within the Regulatory Management Track is to monitor investigator compliance with clinical trial protocols according to applicable regulations and Good Clinical Practice (GCP), interfacing with the Project Manager/Team Leader, Project Team, clinical investigators and other study personnel in order to carry out this responsibility.
Conducts on-site and off-site monitoring activities to ensure investigative sites are complying with clinical trial protocols, FDA regulations, SOPs, ICH and GCP guidelines.
Assists in study start-up process (e.g., identification and initiation of new sites, development of monitoring plan and tools, site staff training, acquisition of clinical supplies, regulatory compliance i.e., IRB, FDA, GCP, etc.).
Stays abreast with and communicates new regulatory information to project team for consideration of impact on study procedures or processes.
Assists with central file development, collection, review, tracking and storage of regulatory documents required in a clinical trial, e.g., FDA 1572, IRB approval, etc.
Creates monitoring visit reports, as well as initial and follow-up communications to sites.
Participates in meetings on an ad hoc basis at various stages of the study (e.g., to present and review the monitoring plan prior to study start-up, to discuss site performance issues based on monitoring visits, etc.).
Via electronic data capture system, participates in off-site monitoring activities and reconciling clinical trial data, including serious adverse events and other reportable events with adverse event, dose management, and other relevant study records.
Bachelor’s degree, with major course works in appropriate health, social science, or biological science field; or equivalent combination of education and experience (including at least 3-5 years of pharmaceutical sponsored clinical trial experience). Knowledge of ICH and GCP Guidelines, planning, implementation, coordination, evaluation, and reporting of clinical trials. Competence in electronic data capture preferred. Clinical trials coordination or monitoring experience preferred. Travel required at approximately 75%. Strong verbal and written communication skills, interpersonal skills, attention to detail and organization required.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Clinical Research Assoc (S)
Location: School of Medicine & Dentistry
Job ID: 196640
Full/Part Time: Full-Time