CRA

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.