CRA II
Hybrid · Osaka, Osaka, Japan or Tokyo, Tokyo, Japan
Job Summary
CRA II role performing site qualification, initiation, monitoring, and close-out visits both on-site and remotely. Responsibilities include evaluating site performance, ensuring regulatory and ICH-GCP/GPP compliance, obtaining and documenting informed consent, maintaining subject confidentiality, performing source document reviews, ensuring accurate CRF data entry, resolving data queries, supporting IP inventory and labelling activities, and maintaining ISF/TMF alignment. The position requires travel up to 75% and collaboration with global teams, including participation in investigator meetings and audits readiness. Minimum qualifications include a bachelor’s degree or RN in a related field or equivalent experience, knowledge of GCP/ICH guidelines and applicable regulations, strong communication and computer skills, and ability to work across complex study components in a real-world late-phase setting. The role may involve deployment to sites and adherence to privacy and regulatory requirements in the US as applicable.
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
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
- Proficiency with computer systems and data management tools used in clinical monitoring
- Experience with site qualification, site initiation, interim monitoring, site management and close-out visits
- Experience with Source Document Review, CRF data accuracy/complete data entry and query resolution
- Familiarity with ISF, TMF and IP inventory/reconciliation
- Understanding of electronic data capture requirements and data integrity controls
- Ability to prepare for and participate in Investigator Meetings and sponsor meetings
- Knowledge of regulatory and SOP requirements and archiving responsibilities
- Willingness to travel extensively and work with multi-country teams
- US ONLY: Site access/privacy considerations as described in employment notices
Additional Requirements
- US ONLY
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