Clinical Research Monitor
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 to ensure investigative sites are complying with clinical trial protocols, FDA regulations, SOPs, ICH and GCP guidelines.
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.
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
Pay Range: $ 58,800 - $ 82,300 Annually
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
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Location: School of Medicine & Dentistry
Full/Part Time: Full-Time