How you’ll spend your day
To be qualified by education, experience and training to assume responsibility for proper conduct of the study.
Before study start:
Comply with all applicable regulations, complete required forms.
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
Read and understand the IB or appropriate information on the drug prior to study start.
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 (for e.g vacutainer labels, dosing label study schedule stations).
Responsible for all clinical or medical aspects of the study hence should personally conduct or supervise the study.
Your experience and qualifications
0- 2 Years of expereince into Clinical Investigator BABE Studies
Female preferred
MBBS
