Pharmacist (Advity)

Roles and Responsibilities

Qualifications:

• B. Pharmacy / M. Pharm

Preferred Skills:

• Data Integrity.

• Procedural Knowledge (SOP).

• Technical & Scientific Knowledge.

• Regulatory Awareness.

• Reporting and Updating./li>

• Continouing Education.

Detailed Responsibilities:

• To receive and Storage IMPs.

• Request for randomization schedule generation from biostatistician according to protocol in coordination with PI.

• Dispensing of different dosage form of IMPs.

• Maitainance of IMPs accountability.

• To perform retention, send back or destruction of IMPs.

• Review of IMPs documents to ensure accuracy, completeness, and compliance with protocol, SOP and regulatory guidelines.

• Manage the Pharmacy according to the SOP’s. and GMP.

• Request and receipt of study specific documents from QA.

• Ensure the appropriate periodic maintenance and calibration of equipments like Humidity Chamber, Cold Chamber and Laminor Air Flow etc.

• Compilation of study specific TMF (prior to study).

• Readiness of the CPUs with the support of HK staff.

• Place indents to procure material / supplies needed for the study.

• Self-checking of protocol training completion.

• Reporting of eligible volunteer’s/subjects for study admission.

• Providing ICD presentations to volunteers in groups.

• Perform admission, discharge, meal distribution, reporting, and monitoring of subjects during the clinical study conduct.

• Supervision of activities of other study personnel (CRTs, RNs) during the conduct of clinical study.

• Compilation and review of study data and ensuring the compliance with SOPs and protocol during the study conduct.

• Compilation of study documents on timely.

• Responsible for submission of study documents (ICDs, CRFs and TMFs) to QC, QA for review and subsequent closure of observations in consultation with Study PIC/ PI or designee.

• Assist the PIC for the archiving of study documents.

• Identification of the SOP / protocol deviations and bring it to the notice of project in-charge for recording.

• Compliance and data integrity during study execution with SOPs and regulatory requirements.