How you’ll spend your day
To be qualified by education, experience and training to assume responsibility for proper conduct of the study.
Comply with requirements of the GCP, EC/Sponsor agreed protocol and Lotus SOP’s applicable regulatory requirements and the ethical principles which have their origin in the declaration Of Helsinki
Review and timely inputs on the protocol (eg dosing information, contradictions, warnings, precautions, adverse events, drug interaction) CRF, ICD and any other document as required for the study.
Obtaining ethics committee approval and clarifying the issues / questions raised by the EC.
Ensure that all study personnel assisting in the trial are aware of their obligations and have been trained on the protocol, study plan and trial related duties and functions respectively to perform duties assigned to them.
Ensuring that all necessary trial related documents are generated and compliant with the protocol.
Responsible for all clinical or medical aspects of the study hence should personally conduct or supervise the study.
Brief the volunteer about the study and the related procedures, encouraging the volunteers to ask questions, answering the questions and then obtaining written informed consent and ensure the same is captured audio-visually.
Enrolling healthy volunteers as per the inclusion / exclusion requirements of the protocol.
Supervision of activities like check-in, dosing, blood sampling and separation as applicable.
Your experience and qualifications
MBBS OR MD
2 Years of experience into BABE Studies
