Premier Research
Analgesia • CNS/Neuroscience • Rare Disease • Pediatrics • Oncology
1001 - 5000
💰 Venture Round on 2016-10
Clinical Research Associate II
2 days ago
Premier Research
Analgesia • CNS/Neuroscience • Rare Disease • Pediatrics • Oncology
1001 - 5000
💰 Venture Round on 2016-10
Description
• Conducting Monitoring visits such as (Qualification, SIV, RMV and COVs) • Site management • Supporting upcoming database lock. • Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations. • Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan. • Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. • Reviews site documents and verifies they are accurate, complete, current, and include required updates. • Maintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts.
Requirements
• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required. • Previous clinical research experience required, completion of CRA training program. • Experience in monitoring complex trials or global trials or equivalent experience with at least 3 years of independent monitoring. • Experience in Oncology, Dermatology, Neurology, Rare Diseases and / or Medical Devices an advantage.
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