New Jersey 732.770.4100

 Clinical Research Project Management

A Clinical Research Project / Study Manager (CRM) is responsible for the monitoring, data collection and analysis, and reporting of clinical trials performed and be in compliance with Ethical practices, ICH , GCP and Clinical Safety guidelines per U.S. and international markets.

The Additional CRA training emphasizes on practical aspects as presentations in the reference to role performed by CRM into industry. See program highlights for more information.






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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 Our program is approachable which provides in-depth knowledge and practical exposure to roles and responsibilities performed by Clinical Research Project Manager / Study Manager. It gives insight into topics including but not limited to:
LIST OF TOPICS :
  1. Risk Based Monitoring (RBM)
  2. FDA Audit process for Clinical Research
  3. Clinical Trial Project Management (CTPM) and Time-lines
  4. Development of Monitoring Plan
  5. Protocol Deviation/Violation Management
  6. Trial Master File and QC Management
  7. Clinical Data Reconciliation and Archiving
  8. Management and Reconciliation of Investigational Product
  9. Advanced Clinical Research Management – Modules 1 thru 4
  10. Planning and Conducting Global Clinical Trials
  11. Management of a Successful Clinical Research Site – Part A & B
Teaching Methodology Available as self-paced training (PIP, pure internet program) Course Reading Material (PowerPoint presentations with Voice-over)
Career Opportunity Pathways Clinical Program Manager, Senior Clinical Research Associate, Clinical Study Manager, Research Business Manager
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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