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About the Role
Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in Clinical Research, with a focus on site management, including oversight of contract CRAs and mentoring of less experienced CRAs.
Responsibilities
- Oversees the monitoring, planning, and execution of clinical trials/research, and data collection activities.
- Contributes to the implementation of clinical protocols.
- Recruits clinical investigators and negotiates study costs with clinical sites.
- Directs human clinical trials, pre- and post-marketing trials, PMS, and clinical research activities.
- Monitors compliance with protocols, J-GCP, GPSP, and SOPs.
- Manages and oversees contract/temporary CRAs to ensure study activities are executed in compliance with protocols, SOPs, regulations, and study timelines.
- Provides day-to-day guidance, performance oversight, and workload management for contract/temporary CRAs, including issue escalation and resolution.
- Mentors and supports junior and less experienced CRAs through coaching, training, and regular feedback.
- Facilitates knowledge sharing and promotes best practices across the CRA team.
- May participate in adverse event reporting and safety monitoring responsibilities.
- May act as a consultant and liaison with clinical sites.
Requirements
- Minimum 3 years of experience as a CRA in the healthcare sector.
Skills
- Site management
- Oversight of contract CRAs
- Mentoring CRAs
- Monitoring clinical trials
- Planning clinical trials
- Execution of clinical trials
- Data collection
- Clinical protocol implementation
- Clinical investigator recruitment
- Study cost negotiation
- Directing clinical trials
- Compliance monitoring
- Protocol compliance
- J-GCP compliance
- GPSP compliance
- SOP compliance
- Contract CRA management
- Temporary CRA management
- Guidance and performance oversight
- Workload management
- Issue escalation and resolution
- Coaching
- Training
- Feedback
- Knowledge sharing
- Best practice promotion
- Adverse event reporting
- Safety monitoring
- Consultation
- Liaison with clinical sites
Location
- Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku
Work Type
- Standard
Experience Level
- Experienced professional individual contributor
- Minimum 3 year experience as a CRA
Education Level
- Bachelor’s degree or above
About the Company
- Abbott is a global healthcare leader, creating breakthrough science to improve people’s health.
- We’re always looking towards the future, anticipating changes in medical science and technology.
- At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.
- You will have access to: Career development with an international company where you can grow the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
- Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Equal Opportunity
- Abbott is an Equal Opportunity Employer, committed to employee diversity.