Ｗｏｒｌｄｗｉｄｅ Ｃｌｉｎｉｃａｌ Ｔｒｉａｌｓ Ｊａｐａｎ株式会社
SUMMARY:
Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs).
Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
RESPONSIBILITIES:
- Perform feasibility studies for potential sites as requested
- Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
- Function in the role of Lead CRA for global studies, coordinating CRAs
- Develop Clinical Monitoring Plan as requested
- Conduct site visit trip report review and provide feedback and edits
- Provide mentoring and guidance to less experienced CRAs and site staff when needed
- Design study specific tools and templates as requested
- Actively participate in study team and investigator meetings
- Actively participate in bid defenses
- Create and conduct training to study team members or colleagues as requested and appropriate
- Work with Project Management to evaluate deliverables and study milestones
- Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
- Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
- Document site visit findings via written reports
- Provide input into the design of protocols and CRFs as requested
フルリモートが可能なグローバルCROです