Clinical Trial Drug Safety Associate
Everest Clinical Research (“Everest”) is a
- service contract research organization (CRO) providing a broad range of
- based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the
- known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a
- service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.
Everest also recently completed the acquisition of August Research. August Research is a European CRO that provides Clinical Operations and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients. The Company has worked on over 120 projects for Phase I-IV clinical trials across multiple therapeutic areas including cardiovascular, infectious disease, oncology and rare disease. The acquisition of August Research establishes a European footprint for Everest to provide
- service offerings to its pharmaceutical, biotechnology and medical devices clients, and other operational capabilities through the Company’s substantive experience and infrastructure across 14 countries in Western and Eastern Europe.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone,
- focus is our tradition, flexibility is our strength…that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and
- focused individuals to join our winning team as Clinical Trial Drug Safety Associate for our August Research location in Bucharest, Romania with opportunities to work remotely in accordance with our Work from Home policy.
Key Accountabilities:
-
- date, complete, and concise. Generate queries for any critical or missing information. Send queries to the Data Manager for posting to the clinical database and/or generate Data Clarification Forms (DCFs) and send queries directly to the study sites. Ensure all case documentation is filed and saved appropriately, including uploading of source files into Argus. Interact with the Everest Medical Monitor to ensure the high quality of case narratives and regulatory report forms and that they conform to Everest’s standards and regulatory requirements.
Watch/CIOMS/E2B) for reportable events for clients’ submission to regulatory authorities and Investigators/Institutional Review Boards (IRBs).
- specific SMPs written by other PV personnel; occasionally draft SMPs.
Qualifications:
- and
- focused).
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