Location: Hyderabad

Experience: 01 - 02

Qualifications & Other Specifics

Qualifications:

- B. Pharmacy / M. Pharm

Preferred Skills:

- Communication.
- Time Management.
- Adaptability.
- Listening.
- Assertive Communication.
- Technical & Scientific Knowledge.
- Data Integirty
- Procedural Knowledge (SOP).
- Regulatory Awareness.

Detailed Responsibilities:

- Request and receipt of study specific documents from QA.
- 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.
- Place indents to procure material / supplies needed for the study.
- Self-checking of protocol training completion.
- 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.

📌 CRA (India)
🏢 Advity Research
📍 India