Cra
4 days ago
**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.
- 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.
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