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Sr Clinical Research Associate

3.00 to 8.00 Years   Ahmedabad   08 Apr, 2024
Zenovel Pharma Services LLP
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaAllied Health Services
EmploymentTypeFull-time

Job Description

    • Take part in monitoring plan meeting
    • Overseeing the progress of a BA/BE studies or clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
    • Checking documents of CRO internal System audit at specified interval and related documents and CAPA Perform on-site/remote monitoring visits i.e. initiation, periodic monitoring, close out meetings, Bioanalytical visits and coordinate with project coordinators/project in-charges at different CROs for clinical trials & BA/BE studies.
    • Prepare the Monitoring Reports and taking follow up for the corrective actions and preventive actions taken by the site to solve all the observations.
    • In addition, providing them suitable suggestions/recommendations if required.
    • Taking part in Audit strategy meeting Conducing on-site/remote audit of BE CROs and phase-I facility Preparation of Audit report and checklist Compilation of the study source documents and submit to QMS for archival Training of the new monitors/auditors and guide them for operation Update the OneDrive with all soft copy of data To perform other responsibility and duties delegated by the director operation and management.

Keyskills :
clinical monitoringclinical research associates

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