This course offers a comprehensive understanding of clinical trial management, designed for individuals aiming to build foundational knowledge in the field of clinical research. Covering essential topics such as clinical trial phases, regulatory guidelines, site management, documentation, and safety reporting, the course provides practical insights into how clinical trials are planned, conducted, and monitored.
Students will gain familiarity with industry-standard tools such as EDC systems and Trial Master File management. The content also includes ethical considerations, Good Clinical Practice (GCP), and global regulatory frameworks including FDA, EMA, and ICH-GCP. Key roles such as Clinical Research Associate (CRA), Coordinator (CRC), Investigator, and Sponsor are clearly explained, helping learners understand responsibilities and workflow within a trial.
Whether you're from a medical, pharmacy, life science, or healthcare background, this course is suitable for those interested in understanding how clinical research operates. It also includes supportive resources like sample templates, study tools, and knowledge checks to reinforce learning.
This course is ideal for those exploring entry-level roles in clinical research, regulatory affairs, or pharmaceutical project support. With clearly structured modules and industry-relevant topics, learners can build competence and confidence in understanding clinical research processes and trial operations.
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