Summarized Purpose:
Clinical Research Coordinator (CRC) to support an ongoing study with data entry, query resolution, and other CRC activities. The ideal candidate will have previous experience working as a CRC and demonstrate a strong collaborative approach. They should be diplomatic, agile, and adaptable, with strong interpersonal skills and an ability to work effectively and constructively with different stakeholders.
Essential Functions:
• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Records all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
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