Clinical Research Associate I
2 weeks ago
Job Summary: We are seeking a skilled Clinical Research Associate I (FSP) to join our team at Parexel.
About the Role:
- Conduct Source Data Verification and Ensure Clinical Trials Data are Submitted in a Timely Fashion: The successful candidate will be responsible for conducting source data verification (SDV) and ensuring that clinical trials data are submitted to data management in a timely fashion.
- Identify and Manage Site-Specific Issues: The candidate will identify issues that may impact the conduct of the study and ensure appropriate closure of all issues.
- Proactively Manage a Greater Investigator Site Workload: The Clinical Research Associate I (FSP) will proactively manage a greater investigator site workload commensurate with experience, ensuring that studies are run efficiently and key study objectives are met.
- Ensure Compliance with Regulations and SOPs: The successful candidate will ensure that studies are run in line with ICH/GCP, local laws, and Client Standard Operating Procedures (SOPs) and procedures.
- Maintain Patient Safety and Report Safety Issues: The candidate will ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.
- Communicate Effectively with Site Staff: The Clinical Research Associate I (FSP) will inform the Principal Investigator (PI) and site staff of all issues and agree and develop corrective and preventative actions with PI and site personnel to close all open issues.
- Manage All Aspects of Site Management: The successful candidate will be responsible for all aspects of site management from collaboration on site selection to study closeout.
- Train Site Staff on Protocol and Client Processes: The candidate will train site staff on the protocol, protocol amendments, and Client processes.
- Understand Product, Protocol, and Therapy Area: The Clinical Research Associate I (FSP) will understand the product, the protocol, and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.
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