※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Salary] 6〜9 million JPY ※Experiences and skills will be considered
Acts as primary site contact and site manager throughout all phases of clinical research studies.
- Develop strong site relationships and ensure continuity of site relationships through all phases of trial.
- Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gain an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Perform remote and on-site monitoring & oversight activities using various tools to ensure:
-Data generated at site are complete, accurate and unbiased
-Subjects' right, safety and well-being are protected
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collect, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM.
- Manage and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Supports and/or leads audit/inspection activities as needed
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider