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Search for Jobs by Diane Brescia

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Senior Clinical Research Associate - Remote  (Science & Biotech)
Toronto , ON M4B 1C9
Recruited by: Diane Brescia | Recruiter | DOCS See all my Jobs

  • Hiring Company: DOCS
  • Industry: Science & Biotech
  • Compensation: To Be Determined
  • Expires: Oct 05, 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 in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient 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.
Qualifications:
• Minimum of a Bachelor of Science degree in a health related field with 5 or more years clinical research experience including at least 5 years CRO/sponsor monitoring.