University of Rochester Clinical Project Monitor, Senior - 218990 in Rochester, New York
Clinical Project Monitor, Senior
School of Medicine & Dentistry
Full Time 40 hours Grade 055 Neuro-Ctr Health & Tech/CTCC
8 AM-5 PM; OCC WKENDS
The responsibility of the Clinical Project Coordinator, Senior 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.
Under general guidance and with some latitude for the exercise of independent judgment and initiative:
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.
Provides support in the 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.)
Supports 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.
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.
Stays abreast with and communicates new regulatory information to project team for consideration of impact on study procedures or processes.
Applies knowledge of ICH and GCP Guidelines, planning, implementation, coordination, evaluation, and reporting of clinical trials.
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.).
Bachelor’s degree and 5 years of experience in clinical research, preferably management experience; or an equivalent combination of education and experience. Experience as a certified pharmaceutical Clinical Research Associate with nursing degree preferred. Knowledge of software preferred.
Competence in electronic data capture and Clinical trials coordination or monitoring experience preferred.
Travel required approximately 75%.
Strong verbal and written communication skills, interpersonal skills, attention to detail and organization required.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled