Sr CRA

Company Overview
Global Pharma Maker

Job Description
 Communicate with Japan Study Leader and third party vendors as needed.
 Conduct site selection activities for verifying adequate qualifications.
 Manage and monitor the responsible sites and ensure their quality appropriately, agreed cost spent and on a timely basis.
 Ensure input the latest site related information in IMPACT at appropriate timing.
 Participate in-house and/or external clinical trial related meeting (ex. Study team meeting, CRA’s meeting, Investigators’ meeting) including the preparations.
 Cooperate with site audit in liaison with QA and a site inspection by regulatory authority.
 Cooperate with resolving the result of SAE reconciliation.
 Ensure inspection ready TMF regarding site related documents. In addition to above, Senior CRA also is to
 Lead a certain number of CRAs (incl. CRO CRAs) to in terms of information management and communication related to site management in study team to keep monitoring quality.
 Contribute to the development of Clinical Operations Japan by joining some projects or initiatives, e.g. Process Ownership responsibilities, CRA training.  Mentor CRAs on monitoring and internal procedures. 【応

Requirements
 At least 3 years of CRA experience.  Demonstrated leadership capability in a team environment successfully.
 Negotiated some complicated issues and/or requirements with site staff.
 Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
Bachelor’s degree (or equivalent), preferably in biological science or discipline associated with clinical research

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