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The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
- Applies knowledge of PRA’s policies and procedures
- Demonstrates excellent written and oral communication
- Demonstrates excellent knowledge of ICH/GCP
- Displays ability to manage investigative sites to facilitate trial deliverables
- Demonstrates ability to escalate issues appropriately
- Conducts monitoring to confirm subject safety and data ntegrity
- Describes and demonstrates the principals of IP accountability
- Identifies scientific misconduct at the site level
- Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
- Mentors CRAs new to the position or company
- Serves as an observation visit leader
- Conducts monitoring evaluation visits
- Assists team lead in the development of trial tools or documents
- Assists with CTM tasks
- Participates in the development of process changes/improvements
- Presents at client meetings/Investigator meetings
- Provides training to trial teams
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