University of Rochester Clinical Project Monitor - 215313 in Rochester, New York
Clinical Project Monitor Job ID 215313Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 053 Neuro-Ctr Health & Tech/CTCCSchedule
8 AM-5 PM; OCC WKENDSResponsibilities
The responsibility of the Clinical Project Monitor, 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 nationwide to ensure investigative sites are complying with clinical trial protocols, FDA regulations, SOPs, ICH and GCP guidelines.
Monitor clinical trial progress through a combination of data review and on-site monitoring visits. Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review). Independently coordinate ongoing and upcoming monitoring assignments. Meet expected timelines for completion of monitoring activities and submission of written monitoring reports.
Plans, creates and develops 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.
Coordinates study start-up process, including the identification and initiation of new sites; development of monitoring plan and tools; site staff training (eg. on policies and practices utilized by industry sponsors in meeting the regulatory requirements for conducting clinical research); 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.
Facilitates and 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, with major course works in appropriate health, social science, or biological science field and 3-5 years of experience in clinical research coordination ; or equivalent combination of education and experience.
Knowledge of ICH and GCP Guidelines, planning, implementation, coordination, evaluation, and reporting of clinical trials.
Competence in electronic data capture and clinical trials coordination or monitoring experience preferred.
Nationwide travel required at 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