Clinical Research Associate I(FSP) Coordinator
2 months ago
Unlocking Success in Clinical Research
Our team at Parexel is dedicated to delivering exceptional results in clinical trials. As a Clinical Research Associate I(FSP), you will play a critical role in ensuring the success of our studies.
Key Responsibilities:
- Source Data Verification and Data Management Conduct thorough source data verification and ensure timely submission of clinical trial data to data management.
- Issue Identification and Closure Identify potential issues that may impact study conduct and work closely with site personnel to ensure appropriate closure of all issues.
- Site Management and Monitoring Proactively manage a greater investigator site workload, ensuring studies are run efficiently and key study objectives are met.
- Regulatory Compliance and Quality Ensure studies are conducted in line with ICH/GCP, local laws, and client standard operating procedures.
- Patient Safety and Reporting Maintain patient safety and report all safety issues correctly according to local and international regulatory requirements.
- Collaboration and Training Collaborate with site staff to ensure they are adequately trained on the protocol, protocol amendments, and client processes.
- Progress Reporting and Issue Management Report on study progress after each visit and proactively manage issues to closure.
- Documentation and Record-Keeping Maintain accurate site-level information on corporate clinical trials registry and ensure Electronic Library and Records Archive (ELARA) and/or Client Trial Master File (TMF) are complete and accurate.
- Compliance and Training Comply with required training curriculum, complete timesheets accurately, and maintain a working knowledge of Parexel processes and ICH-GCPs.
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