חברות הייטק בישראלPremier ResearchSenior Clinical Research Associate

Senior Clinical Research Associate

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Premier Research· Biotechnology Research
Israelפורסמה החודש

כישורים מהמשרה

Clinical ResearchData IntegrityPatient SafetyMonitoringClinical TrialsRegulatory ComplianceSite ManagementTrial Master FileICH/GCPHealthcareBiotechnologyMedtechPharmaceuticalsDocumentationQuality AssuranceTeam Collaboration

תיאור המשרה

Premier Research is looking for a Senior Clinical Research Associate to join our Clinical Monitoring and Site Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You'll Be Doing 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. Understands the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates What We Are Searching For 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 At least 4+ years’ experience in clinical trials This position is offered as a 0.75 FTE with a contract duration of 6-12 months. The study is in the area of Obstetrics with site locations across Israel, mainly in Jerusalem. Average days on site will be up to 6 days per month.
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על Premier Research

Premier Research International LLC (Premier) is a global leader in clinical research and consulting services with expertise in driving an efficient and effective path to market for the life sciences industry. Premier is built with the needs of biotech in mind, turning breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value. Leveraging deep therapeutic expertise, innovative technology, and product development operational proficiency—from preclinical planning to clinical trial execution and commercialization—our integrated approach offers personalized, end-to-end solutions to identify the pertinent data and insight necessary to make informed decisions earlier and deliver accelerated development timelines for a smarter, faster path to approval. Through our commitment to partner boldly, deliver impact, and foster community, we’re driving change that advances research and improves lives while creating meaningful opportunity for patients, customers, and all Premier team members. Follow our page to learn more about our work—and explore career opportunities to be part of the transformation.

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