Extensive knowledge pertaining to all phases of clinical trials in different therapeutic areas such as Oncology, Central Nervous system and cardiology in accordance with the applicable ICH, GCP, FDA and local regulation
Remarkable Knowledge in all areas of research including budgeting, GCP, IRB protocol submissions, on-going regulatory and IRB phases and IND safety reporting.
Demonstrated competencies in managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting.
Developed and authored Case report Forms (CRFs)
Created and Reviewed Informed consent forms
Detailed knowledge of study specific regulatory documents and able to update, and maintain study specific trial master files and system.
Knowledge of adverse events and serious adverse events reporting to the regulatory authority and FDA according to the GCP guidelines.
Specialist Trial Master
Clinical Trial Coordinator
Clinical Research Scientist
Clinical Project Manager
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