Company OverviewGlobal 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