Category

Description

• Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators.
• Critically reviews and analyzes 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.
• Ensures quality of data submitted from study sites and assures timely submission of data.
• Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH and/or FDA GCP Guidelines.
• Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives.
• Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
• Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
• Appropriately escalates serious or outstanding issues to line manager and project team members.
• Proactively communicates and escalates with all internal and external stakeholders any issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.

• Minimum of a Bachelor of Science degree in a health related field with a minimum of 5 years clinical research experience
• Previous proven experience in monitoring Oncology studies is desired.
• Demonstrated success in working independently
• Strong communication and leadership skills
• Ability to work independently and travel up to 50% of time.
• Fluent in Russian and English.

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