Administration of Investigation drug products to the study subjects.
Ensures that feasibility and readiness of the clinical unit, emergency unit and equipment’s for conduction of the study activities.
Ensures that regulatory related documents, approved Protocol and Informed consent forms etc., are available with the Trial Master File.
Arrangement of all study related documents as per the protocol requirements.
Ensures that the all study related volunteers documents are compiled and available for the check-in activity.
Coordinate for subject enrollment process during check-In and end of the study.
Performed the study related activities as per GCP, Principles and ethics, the applicable regulatory requirements, protocol and its amendments.
Obtained and documented the informed consent in compliance with the applicable regulatory requirement(s), GCP and ethical principles.
Training the subjects on dos and dons during the study.
Coordination with investigator and coordinators for drug administration activity.
Administration of Investigational drug products to the study subjects.
Coordination with the clinical staff for drug administration, sample collection, vitals checking and processing etc., is performed according to the protocol.
Reporting of adverse events to investigator / physician for adverse event management.
Coordination with the dietician for standardized diet distribution as per the study protocol.
Ensures all withdrawals and dropouts of study subjects are reported to the Coordinators.
Ensures subject compliance to all the study related activities.
Ensures timely and accurate transcription of data from the source documents
Desired Candidate Profile: Interested male applicants with eligible qualification can send their profiles to [email protected] and can also walk in to below address with profiles and academic documents.
