Study Custodian

Axis Clinicals; Hyderabad; On-site; INR 250,000 - 400,000; Full time

Job summary

Axis Clinicals is seeking a dedicated professional to support clinical study operations on site in Hyderabad. The role involves coordinating study forms with the study coordinator, managing subject flow, drug administration, and sample handling in accordance with protocol and SOPs.

Responsibilities include equipment checks, bio-sample processing, label generation, safety assessments, and compiling study documents for QA, along with assisting in clinical report preparation and consent process.

Qualifications

• Bachelor of Pharmacy with PCI registration.

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

Education

Bachelor of Pharmacy (B.Pharm) PCI registered

Job description

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