How you’ll spend your day
To ensure that the clinical study is conducted according to the approved protocol and applicable regulatory requirements.
To protect rights, safety and welfare of subjects.
Management of Investigational Products.
To ensure that sufficient number of qualified medical, paramedical, and clerical staff is available to conduct the study.
To ensure that all staff assisting in study is adequately trained on the protocol, investigational product and their duties.
To be aware of regulatory requirements and acceptable standards for conduct of clinical trial and protection of human subjects.
To ensure that the data is complete, accurate, legible and internally consistent and maintain timelines.
To take all study related medical decisions.
To ensure that adequate medical care is provided to the subject for any adverse event, including clinically significant laboratory values.
In case of health related problems, the investigator should inform the subject's primary physician about the subject's participation in the trial, if the subject has a primary physician and if the subject agrees to the primary physician being informed.
To Review AE / SAE reporting forms after it is filled by the physician / designee.
To Provide timely inputs on the protocol
To conduct study in compliance with protocol approved by IEC, sponsor and regulatory agencies whenever applicable.
To document and explain any deviation from the approved protocol.
To ensure initiation of study and proper conduct of study in compliance with the study protocol and GCP requirements and communicate with IEC about any deviation in the protocol.
Your experience and qualifications
MBBS OR MD
2 – 4 years of experience into Principal Investigator
