Clinical Research Associate
What you will be doing:
- Conduct site qualification, initiation, monitoring, and closeout visits and create documentation of such through accurate and detailed visit reports.
- Monitor source documents to EDC for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria
- Review all source records for patient safety and ensure complete documentation of all subject safety events.
- Review regulatory files to ensure complete, accurate, and up-to-date regulatory compliance at the site.
- Ensure compliance with protocol and overall clinical objectives.
- Train site personnel on study procedures and provide documentation of training. Ensure that study personnel is qualified by experience and training to perform assigned tasks.
- Ensure investigator involvement in the study and IRB/EC oversight.
- Follow through after visit to outstanding requests/needs are fulfilled and raise issues of significance to the appropriate level for resolution.
- Able to help site navigate informed consent issues and support IRB approval process.
- Assist in organizing documentation for regulatory submission, including IRB and/or PMDA submissions as needed.
- Create electronic copies of submitted documents and file all regulatory correspondence in the RMF
- Responsible for accurate and timely maintenance of both electronic and paper files and organizing site study binders
- Work closely with other CRAs, locally and globally, for coverage in collecting and reviewing regulatory documentation and assuring consistency between RMF and site files.
- Generate and maintain study documents as necessary and keeps accurate records of all essential study material(s).
- Responsible for accurate and timely oversight and maintenance of RMF.
- Proper and timely management of all relevant study documentation and standardized processing across all studies, per applicable SOPs.
What you have:
- Minimum of a 2 – 4 -year University degree, preferably in the life sciences field, and basic familiarity with medical terminology
- At least 2-3 years of relevant industry experience in a clinical research environment, preferable from the Medical Device industry.
- Basic computer skills with proficiency in Microsoft Word and Excel required, PowerPoint and Database experience desirable
- Ability to foster relationships with clinical sites and colleagues
- Ability to support several projects simultaneously, a flexible working style, and attention to detail are essential
- Able to work independently with excellent time management skills
- Excellent work ethic with a desire to be a valuable contributing team member
- Preferred location in the Tokyo area
- Proficient in English is a MUST.
- Knowledge of clinical trial processes and regulations in Japan
- Understanding of principles, implementation, and maintenance of regulations.
- Approximately 50% travel that will vary over time, including limited international travel to the USA, and Israel (able to obtain international travel passport, entry permits, and visas, where required).
- Being introduced by an Insightec employee
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