job title: clinical research associatte(advity)

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.