Description
We are seeking a Clinical Research Coordinator to join our team in Tokyo. As a Clinical Research Coordinator, you will be responsible for ensuring compliance with regulatory requirements and guidelines, collecting and tracking essential documents, and liaising with internal and external stakeholders.
Job Overview The successful candidate will serve as primary contact with investigative sites during study maintenance and site startup activities. You will be responsible for collecting required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within agreed timelines.
Summary of Responsibilities
- Develop awareness of regulatory legislation, guidance, and practice in assigned countries with senior staff support
- Assist senior staff in compiling, preparing, submitting, and obtaining approval of submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements
- Liaise with internal and external vendors for Regulatory Authority submissions
- Perform a review of final submission documents as applicable
- Organize communication related to submissions/outcomes within Fortrea
- Escalate study issues appropriately and in a timely fashion
- Perform other duties as assigned by management
In Country Specific Tasks (Global)
- Serve as primary contact for investigative sites and collect required documents in a timely manner
- Collect and track necessary documents, perform quality review, formatting, and compilation of final documents for site activation and maintenance
- Ensure assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality, and applicable laws and guidelines
- Update study documents when there are changes in study personnel/study amendments
- Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis
Clinical Trials Information System (CTIS) Tasks (Specific Centralized Role for EU)
- Upload submission documentation to CTIS under supervision as applicable
Qualifications (Minimum Required)
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
Experience (Minimum Required)
- Minimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines
- Demonstrated basic understanding of the clinical trial process