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Immediate Job Opportunity for Principal Investigator-clinical Research

Keywords / Skills : Clinical Trails, Clinical Investigator, pharma investigator, pharmaceutical investigator, medical investigator, Principle Investigator

2 - 7 years
Posted: 2019-01-09

Job Description
Job Description:

Detailed Role and Responsibilities

MBBS and MD Pharmacology is must Be qualified by education, training and experience to assume the responsibility for the proper conduct of the trial.
Meet all the qualifications specified by applicable regulatory requirements.
Provide evidence of qualification through up to date curriculum vitae and Lotus SOPs, applicable regulatory requirements and the ethical principles which have their origin in the declaration of Helsinki.
Ensure that Ethics Committee approval is obtained and issues /questions raised by IEC are clarified.
Permit monitoring and auditing by sponsor and inspection by regulatory authorities.
Ensure that the protocol is scientifically sound and gives a clear detailed description of trial activities.
Provide timely inputs on the protocol (for e.g. dosing information, contraindications, warnings, precautions, adverse events, drug interactions).
Be responsible for all clinical or medical aspects of the study.
Read and understand the IB or appropriate information on the drug prior to study start.
Comply with all applicable regulations, complete form 1572 and 3455 if applicable.
Delegate study personnel for study related activity after confirming that they have adequate training and qualified for performing their tasks.
Review all SAE reporting forms after it is filled by the designee.
Ensure that all study reports are accurate and consistent with the source data and authorize the same.
Personally conduct or supervise the study.
Principal Investigator may delegate suitably qualified study personnel for following activities:
To brief the volunteer about the study and the related procedures, encourage the volunteers to ask questions, answer the questions and then obtain written informed consent.
To ensure that other people assisting in the trial are aware of their obligations.
To obtain ethics committee approval and clarifying the issues / questions raised by the IEC.
To maintain the accountability of the clinical supplies from receipt till study completion.
To check for compliance with the randomization schedule during dispensing.
To train all the study personnel on the protocol, study plan and trial related duties and functions respectively

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