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 hr@qpsbioserve.com and can also walk in to below address with profiles and academic documents.

Skills Required: Clinical ,gcp, Clinical Research