Principal Investigator

Role & responsibilities:

• Ensures that qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical studies.
• Maintaining current, up-to-date curriculum vitae.
• Assuming responsibility for the conduct of the clinical investigation.
• Signing the protocol
• Documenting the financial aspects of the trial.
• Disclosing conflicts of interest as described in the regulations.
• Ensuring adequate number of qualified staff and adequate facilities for conductance of the study properly and safely.
• Ensures that all persons assisting with the study are adequately informed about the protocol, the investigational product(s), and their study-related duties and functions.
• Ensuring that medical care is provided to a subject for any adverse event(s) that is reported.
• Informing a subject when medical care is needed to treat an inter-current illness.
• Provide information regarding adverse events and serious adverse events to the IRB/IEC.
• Possessing a thorough understanding of the requirements of each protocol.
• Ensuring recruitment goals are reasonable and attainable.
• Assessing overall protocol feasibility.
• Following the trials randomization procedures.
• Ensuring that the informed consent form contains the entire Essential and additional elements required.
• Conduct of the clinical studies specified by the applicable regulatory requirement(s), the IRB/IEC requirements and/or the regulatory authorities.
• Conduct the study as per the principles of ethics and is compliance with Good Clinical Practices (GCP).
• Attending education workshops.
• Reviewing professional publications.
• Participating in professional societies
• Maintaining a list of qualified persons and their corresponding trial-related delegated duties.

Preferred candidate profile to an email : [email protected]