Study Custodian (Hyderabad)

Study Custodian (Hyderabad)

13 Aug
|
AXIS Clinicals
|
Hyderabad

13 Aug

AXIS Clinicals

Hyderabad

Role & responsibilities

- Coordinate with the study coordinator regarding the study specific forms and keep the requisition for receiving the study specific forms from QA.
- Handling the subject check-in, check-out, drug administration, meal distribution, glucose preparation and administration as per protocol/ SOPs.
- Ensure functioning of equipments in the clinic, before & during clinical study.
- Centrifugation, separation, segregation, storage, and transfer of bio-samples.
- Generation of labels as per requirements of the specific study.
- Safety assessments for smooth conduct of the study as per protocol, SOPs and GCP.
- Compilation of CRF, clinical raw data and other study specific documents and submission to QA for retrospective audit and archival.




- Supervising various activities of clinical phase of the study and report to PI/CI/Study coordinator of the study.
- Review all the study documents completeness and complying with the protocol and SOP requirements and report to PI/CI of the study.
- Assisting the study coordinator for preparation of clinical report.
- Distribution of ICFs to the volunteers during the consent process.
- Disposal of Bio-waste.
- Procurement study requirements in consultation with PI/CI/Study Coordinator

Preferred candidate profile

Bachelors of Pharmacy with PCI registration

📌 Study Custodian (Hyderabad)
🏢 AXIS Clinicals
📍 Hyderabad

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