EG - Clinical Research Associate (Contractor)

[1:35 PM] Yin, Yaping

Clinical Research Associate (Monitor)

Location:

China

Role Summary:

To collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. To monitor investigator sites in compliance with Pfizer SOPs, ICH/GCP and local laws so that site performance targets are achieved and that the company’s image with its external customers is enhanced.

Responsibilities:

 Monitoring

• Conduct SDV and ensure clinical trials data are submitted to data management in a timely fashion.
• Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues.

Management of Investigator Sites

• Proactively manage a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met.
• Ensure studies are run in line with ICH/GCP, local laws and Pfizer SOPs and procedures.
• Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.
• Inform the PI and site staff of all issues.
• Agree and develop corrective and preventative actions with PI and site personnel to close all open issues.
• Responsible for all aspects of site management from collaboration on site selection to study closeout.
• Train site staff on the protocol, protocol amendments and Pfizer processes.
• Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.
• Interact with health care professionals in a manner, which enhances Pfizer’s credibility with the customer.

 Data Quality

• Ensure that data monitored meets target quality standards.
• Ensure that data is entered into Pfizer systems in a timely manner.

Reporting

• Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.
• Ensure all issues are correctly identified and catalogued.
• Proactively manage issues to appropriate closure.
• Maintain accurate site-level information on corporate clinical trials registry.

Documentation

• Obtain critical information to enable generation of IIP documentation.
• Assist CTA in gathering IIP documentation where required to ensure timely site set up.
• Maintain the SMF and SMF log.
• Ensure ELARA and/or PTMF is complete and accurate.
• QC relevant documents in ELARA and/or PTMF in a timely manner.
• Generate site monitoring reports.
• Maintain all appropriate monitoring logs.

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