CRA II, Home Based - CNS Studies
- Contract Type
I am currently looking for a CRA II with 12-18 months' experience on behalf of a global CRO. You will be responsible for monitoring all clinical trials within the CNS therapy area. This is a home based position though can also be based from the company's Berkshire headquarters.
• Assure compliance with CFR, ICH and GCP guidelines and SOPs.
• Maintain current regulatory documentation according to Essential Regulatory Document Guidelines and TMF Plan.
• Assume responsibility for site management and site staff performance
• Participate in all types of site visits.
• Ensure compliance with all protocol requirements.
• Ensure effective patient identification and recruitment plan is in place.
• Ensure timely reporting of AEs/ SAEs and Protocol Violations.
• Perform observation visits with less experienced CRAs.
• Perform source document verification (SDV) according to contractual requirements.
• Ensures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).
• Degree educated the science/health care field or nursing degree or equivalent
• Experience in monitoring clinical trials preferably within a CRO
• Experience within the CNS therapy area
• Must have valid, current driver’s license
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