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Job description :
Duties:
• Identifies, evaluates, and recommends new potential investigators/sites on an on-going basis through medical community networking or internal requests, to assist in the placement of planned clinical studies with qualified investigators.
• Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits.
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, tactful and objective manner.
• Reviews site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations.
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Qualifications :
Requirements:
• Possess knowledge typically attained through at least a Bachelors degree (or equivalent) in Biology or health related field with at least 1 year must be clinical research monitoring.
• Has advanced and thorough knowledge related to ICH GCP Guidelines, and/or FDA GCP regulations, and applicable local regulations.
• Able to work independently with minimal supervision
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