Operations Executive

Not Disclosed
0-2 Years Full Time
Telangana, IN

Vacancy: Not Disclosed Posted: 9 months ago Applicants: 0
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Job Description

  • 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 volunteer's 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 do's and don'ts 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
  • Interested applicants with eligible qualification can send their profiles to and can also walk in to below address with profiles and academic documents.

Skills Required: Clinical ,gcp, Clinical Research