Summarized Purpose:
\nClinical 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.
\n \nEssential Functions:
\n• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
\n• Records all patient information and results from tests as per protocol on required forms.
\n• Where required, may complete IP accountability logs and associated information.
\n• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
\n• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
\n• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
\n• 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.
\n• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
\n• Adheres to company COP/SCOP.
\n• 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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