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Clinical Site Monitor- Remote  (Science & Biotech)
Lexington , KY 40550
Recruited by: Diane Brescia | Recruiter | DOCS See all my Jobs

  • Hiring Company: DOCS
  • Industry: Science & Biotech
  • Compensation: To Be Determined
  • Expires: Oct 06, 2019
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Job Description

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits.
• Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements.
• 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. This includes, but is not limited to: - Manages multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
• 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.
• Facilitates the Regulatory Compliance audit process, as needed.
• Provides monitoring assistance to site monitor colleagues, as requested, in addition to serving as a mentors to other colleagues as assigned.
• 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 3 or more years clinical research experience including at least 3 years CRO/sponsor monitoring. Oncology experience preferred.