Clinical Research Associate II
Fortrea
full-time
Posted on:
Location Type: Hybrid
Location: Tokyo • 🇯🇵 Japan
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements.
- Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
- Prepares and implements project plans related to Clinical Monitoring responsibilities.
- Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
- Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
- Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
- Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
- Ensures adherence to global quality control and CRA performance metrics.
- Ensures audit readiness at site level.
Requirements
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- A minimum of 2 years of Clinical Monitoring experience.
- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- Fluent in local office language and in English, both written and verbal.
- Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
- Ability to work with minimal supervision.
- Understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow-up of SAEs.
- Good planning, organization, and problem-solving abilities.
Benefits
- Competitive salary
- Flexible working hours
- Professional development
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical MonitoringICH GCP GuidelinesRegulatory RequirementsMonitoring ProceduresClinical Trial ProcessSource Document ReviewSource Document VerificationData IntegrityeTMFSAE Reporting
Soft skills
PlanningOrganizationProblem-solvingIndependenceCommunication
Certifications
Nursing LicensureUniversity Degree in Allied Health