Role & responsibilities:

- To coordinate and oversee the conduct of BA/BE clinical studies in accordance with study protocols, Positive Clinical Practice (GCP), applicable regulatory requirements, SOPs, and Ethics Committee requirements while ensuring volunteer safety, protocol compliance, and accurate documentation.

- Ensure study materials and essential documents are available before study initiation.

- Ensures that regulatory related documents, approved Protocol and Informed consent forms etc., are available with the Trial Master File.

- Ensures readiness of the clinical unit, emergency unit and equipments for conduction of the study activities.

- Arrange of all study related documents as per the protocol requirements.

- Verify informed consent has been obtained before any study procedures.

- Coordinate check-in and check-out activities.

- Ensure protocol procedures are performed according to the schedule.





- Training the subjects on do s and donts during the study

- Coordinate with investigator and coordinators for drug administration activity

- Coordinate with the clinical staff for drug administration, sample collection, vitals checking and processing etc., for performing according to the protocol.

- Ensure correct dosing and monitor post-dose activities.

- Reporting of adverse events to investigator / physician for adverse event management

- Coordinate with the dietician for standardized diet distribution as per the study protocol .

- Review source documents and CRFs for completeness.

- Reconcile study documentation.

- All other internal activities as assigned by Department head and Team lead.

Preferred candidate profile : can send their profile to [email protected]

📌 Clinical Research Executive/Associate (Hyderabad)
🏢 QPS Bioserve
📍 Hyderabad