Premier Research
Premier Research is a leading clinical research organization focused on supporting innovative biotech companies in transforming life-changing ideas and breakthrough science into new medical treatments. With extensive capabilities in clinical research and product development, Premier Research offers a comprehensive suite of services including regulatory consulting, real-world and late-phase studies, and expertise across a range of therapeutic areas such as rare diseases, cell and gene therapy, oncology, dermatology, and pediatrics.
Analgesia • CNS/Neuroscience • Rare Disease • Pediatrics • Oncology
1001 - 5000 employees
Founded 1989
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
💰 Venture Round on 2016-10
Senior Clinical Research Associate
March 12
Premier Research
Premier Research is a leading clinical research organization focused on supporting innovative biotech companies in transforming life-changing ideas and breakthrough science into new medical treatments. With extensive capabilities in clinical research and product development, Premier Research offers a comprehensive suite of services including regulatory consulting, real-world and late-phase studies, and expertise across a range of therapeutic areas such as rare diseases, cell and gene therapy, oncology, dermatology, and pediatrics.
Analgesia • CNS/Neuroscience • Rare Disease • Pediatrics • Oncology
1001 - 5000 employees
Founded 1989
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
💰 Venture Round on 2016-10
📋 Description
• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines. • Maintains submission of expenses according to travel and expense requirements within company guidelines. • Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations. • Plans day to day activities for monitoring of a clinical study and sets priorities per site. • 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. • Has an understanding of the required essential documents according to ICH/GCP Section 8. • Reviews site documents and verifies they are accurate, complete, current, and include required updates.
🎯 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. • At least 4+ years’ experience in clinical trials as a CRA.
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