Monitor is responsible to ensure that the trial is conducted and documented properly.
Acting as the main line of communication between the sponsor and the investigator.
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.
Ensure input the latest site related information in IMPACT at appropriate timing.
Participate in-house and/or external clinical trial related meeting.
Cooperate with site audit in liaison with QA and a site inspection by regulatory authority.
Ensure inspection ready TMF regarding site related documents.

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.
Preferred experience to collaborate with external partners.
Performed monitoring activities from qualification visit to closure visit as a CRA.
Bachelor’s degree (or equivalent), preferably in biological science or discipline associated with clinical research.

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Senior Clinical Research Associate, Oncology

Key skills