Overall site management activities and project manager support:
-Assist project manager in developing protocol and CRFs, maintaining project timeline, managing study budget, negotiating and executing site contracts and payment.
-Develop study specific procedures/work instructions and tools and manuals for the trial.
-Perform monitoring activities including site qualification visits, site start-up, interim monitoring visits with SDV and site close-up visits.
-Tracks and reports progress of studies including patient enrollment/screening, data collection, adverse event documentation etc.
-Support the clinical process for collection, maintenance, storage, and archival of essential clinical trial documents (trial master files)
-Assist project manager in regulatory submission with the trial data.
|応募資格||-Bachelor’s-level degree required.
-Experience in clinical/scientific research in medical devices/pharmaceutical industry required.
-5+ years of clinical monitoring required.
-Willingness to travel
-Excellent interpersonal and organizational skills.
-Detail oriented and good problem solving ability.
-Ability to work on cross-functional teams and with multiple projects.
-Excellent computer skills
-TOEIC score of 650 or more preferred.