CRA II
Hybrid · Osaka, Osaka, Japan or Tokyo, Tokyo, Japan
Job Summary
CRA II at Syneos Health is responsible for site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice compliance. You will evaluate site performance, communicate/escalate issues, and develop action plans; maintain knowledge of applicable guidelines, regulations, and SOPs; verify informed consent and protect patient confidentiality; assess factors affecting subject safety and data integrity; perform source data review and ensure CRF accuracy; apply query resolution remotely and on site; support IP inventory, labeling, and storage; reconcile ISF with TMF; train site staff; assist in patient recruitment and retention strategies; travel up to 75% with potential deployment to Real World Late Phase activities; participate in sponsor and investigator meetings and contribute to audit readiness. Strong knowledge of GCP/ICH and ability to work in global teams across sites is required.
Required Qualifications
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Ability to manage required travel of up to 75% on a regular basis
- Excellent communication, presentation and interpersonal skills
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