University of Rochester Clinical Research Assoc (S) - 224205 in Rochester, New York
Clinical Research Assoc (S)
School of Medicine & Dentistry
Full Time 40 hours Grade 053 Neuro-Ctr Health & Tech/CTCC
8 AM-5 PM; OCC WKENDS
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 remote monitoring activities nationwide to ensure investigative sites are complying with clinical trial protocols, FDA regulations, SOPs, ICH and GCP guidelines. Verifies that trial data is consistent with patient clinical notes and other source documentation (source data verification/review). Independently coordinates ongoing and upcoming monitoring assignments. Meets expected timelines for completion of monitoring activities. (25%)
Develops and completes monitoring visit and/or teleconference reports, as well as initial and follow-up communications to sites within the expected timelines as outlined in the Monitoring Plan.
Participates in the development and implementation of Quality and Risk Management Plans (QRMP) and associated Risk Assessment Categorization (RACT).
Performs risk based and centralized data review according to Monitoring Plan and QRMP/RACT. Applies root cause analysis, critical thinking, and problem-solving skills to identify site processes failure and propose corrective/preventive actions to bring the site into compliance and decrease risks.
Via electronic data capture system, participates in off-site monitoring activities and reconciliation of clinical trial data, including serious adverse events and other reportable events with concomitant medications, medical history, 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.)
Other projects and job duties as assigned.
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. (experience in bio/pharma/CRO preferred)
Knowledge of ICH, GCP Guidelines, and local regulatory authority regulations regarding planning, implementation, coordination, evaluation, and reporting of clinical trials.
Competence in electronic data capture systems including eConsenting.
Familiarity with risk based modeling approach and associated software.
Nationwide travel may be required up to approximately 40%.
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