The JCL Certificate course in Clinical Research is a six month course with the right blend of practical exposure, theoretical knowledge and emphasis on management and soft skills in order to make a aspirant ready to take on any role in the clinical research industry.
The certificate course comprises of two main parts:
CORE COURSE (Fundamentals)
Introduction to Clinical research.
Principles of GCP and Schedule Y.
Phases of Clinical Trials and Drug Development Process.
Clinical Research Terminology.
Ethical and Regulatory Considerations.
Informed Consent – Elements and Documentation
Essential documents
Basics in Statistics
ADVANCED COURSE
Trial design and Protocol Writing
CRF Design
Regulatory affairs
Informed Consent Process
Management and soft skills training
EC Correspondences
Site and Investigator selection
Site contract and Budget
Project Management
Study team responsibilities
Subject recruitment and retention
Source Documentation
Safety reporting (Clinical safety and Pharmacovigilence)
Fundamentals of monitoring
Data Management
Statistical methods in clinical trial
Fundamentals of auditing and inspection
Management and soft skills training
At JCL we not only emphasize on technical skills and knowledge of clinical research but also management and soft skills which are vital in the present scenario. JCL offers courses in communication and interpersonal skills, time management, conflict resolution and computer basics so that students are ahead of their peers in this competitive industry