Job title: Clinical Research Associate (Advity)

Roles and Responsibilities

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.