Principal Investigator

QPS Bioserve; Hyderabad; On-site; INR 420,000 - 660,000; Full time

Job summary

QPS Bioserve is seeking a candidate to oversee clinical studies, ensuring ethical conduct and compliance with regulatory requirements in Hyderabad. The role includes protocol signing, staff coordination, and safeguarding participant safety.

Responsibilities emphasize documentation, disclosure of conflicts, engagement with IRB/IEC, and adherence to GCP standards. Ongoing education and professional involvement are encouraged.

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 fonctions.
• 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.

Job description

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.