Principal Investigator - Clinical - MBBS

Designation : Principal Investigator - Clinical

We need only MBBS candidate. BAMS candidate will not fit for the position.

Responsibilities :

- Principal Investigator in BA/BE studies.

- To design, conduct, perform, record, analyze and report for BA/BE studies and clinical trials.

- The investigator is responsible to conduct and complete the project in compliance with the protocol agreed with the sponsor

- To ensure an availability of adequate number of qualified staff and facilities for proper and safe conduct of BA/BE studies and clinical trials and also responsible for protocol training and job delegation to staff members.

- Management of adverse event and serious adverse event and to ensure adequate medical care for the subject during adverse event and whenever required.

- To ascertain rights, safety and well being of the subjects.

- To communicate with IEC for approval clinical project protocol and consent and other project related documents and any amendments thereof.

- Responsible to monitor and audit the progress of project.

- To ensure appropriate use of the investigational products and its required documentation.

- To ensure GCP and the applicable regularly requirements compliance.

- To ensure conduction and completion of the project.

- Responsible for all clinical project related medical decisions and also providing reason if subject is withdrawn from a clinical project.

- To identify protocol deviation (protocol without agreement by the sponsor & IEC.

- To provide any updates for subject recruitment procedures and any other written information before initializing a clinical project to IEC.

- To monitor and ensure about adverse events and lab abnormalities identified in the protocol as critical to safety evaluations.

- To ensure about project related documentation like CRFs, source document etc. whichever applicable.

- To inform regulatory authorities for Serious adverse event as per protocol / regulatory requirement.

- To provide project updates to IEC.