New Jersey 732.770.4100

 Clinical Research Monitor Training

A Clinical Research Monitor (also called: Monitor, Clinical Monitor, Trial Monitor or Medical Monitor) is a professional employed by a pharmaceutical, medical device manufacturing, or clinical research organization (CRO) to support, monitor, and conduct clinical trials. CRM monitors the site activities to ensure they are conducted in accordance with the study protocol, standard operating procedures (SOPs), ICH-GCP Guidelines, and other required regulations.







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Admission Requirements

Recommended: minimum a Bachelor degree in biochemistry, biomedical engineering, biotechnology, chemistry, clinical data management, medicine, pharmaceutical engineering, industrial pharmacy, industrial chemistry, public health, pharmacy, pharmaceutical business, pharmacology, or toxicology.

Curriculum Overview

This training is offered to individuals willing to develop the technical skills and knowledge pertaining to roles and responsibilities of Clinical Research Monitor. This course provides practical knowledge in drug discovery research process and clinical trials (pre-clinical trials and following phase one to phrase four). In particular: FDA and EMEA Regulations, ICH Guidelines for Good Clinical Practice, Institutional Review Board (IRB), SOP Development, Conducting Multinational Clinical Trials, Communication with Cross Functional Team, Overview of Clinical Protocol, Role of CRA (Monitoring), Clinical Protocol Design and Development, Subject Recruitment and Informed Consent, CRF Design and Development Monitoring Prospective, Study Initiation, Planning for Site Visits, Site Monitoring, Source Documentation, Retention, and Compliance, Drug Accountability Plan, Investigator-Monitor Meeting and Follow Ups, Introduction to Adverse Events and Classification, and Clinical Trial Onsite Audit and Understanding Monitoring Worksheets

Teaching Methodology

Available as self paced training (PIP, pure internet program)

Career Opportunity Pathways Clinical Research Monitor, Clinical Monitor, Trial Monitor, Medical Monitor
Duration 45 days
Program Brochure 'Click here'   to download program brochure.
Contact Information NJ Office - (P) 732.770.4100
Fax - 888.532.0210
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