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 Valuable 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]
📌 Principal Investigator (Hyderabad)
🏢 QPS Bioserve
📍 Hyderabad