New Jersey 732.770.4100
Clinical Research Monitor Training
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.
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
Available as self paced training (PIP, pure internet program)
|Career Opportunity Pathways
||Clinical Research Monitor, Clinical Monitor, Trial Monitor, Medical Monitor|
to download program brochure.|
||NJ Office - (P) 732.770.4100|
Fax - 888.532.0210
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