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CRA II - Internal Medicine (Biotech)
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The role
Conduct site visits including selection, initiation, monitoring, and close-out in alignment with contracted scope and GCP/ICH guidelines.
Ensure trial activities meet protocol requirements, regulatory standards, and sponsor expectations while safeguarding patient safety.
Perform source data verification, query resolution, and meticulous documentation to maintain high-quality trial data.
Coordinate with investigators, site staff, and cross-functional teams to support study milestones and enrollment efforts.
Prepare and contribute to trial master file documentation, monitoring visit reports, and issue escalation as needed.
Travel to sites as required; demonstrate strong organizational skills, effective communication, and proactive problem-solving in a fast-paced environment.
Ensure trial activities meet protocol requirements, regulatory standards, and sponsor expectations while safeguarding patient safety.
Perform source data verification, query resolution, and meticulous documentation to maintain high-quality trial data.
Coordinate with investigators, site staff, and cross-functional teams to support study milestones and enrollment efforts.
Prepare and contribute to trial master file documentation, monitoring visit reports, and issue escalation as needed.
Travel to sites as required; demonstrate strong organizational skills, effective communication, and proactive problem-solving in a fast-paced environment.
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