Contracting – Antwerpen Ensure the safety and well-being of study subjects at assigned clinical sites. Support the operational execution of clinical trials and ensure high-quality data collection. Perform trial activities in compliance with SOPs, GCP, and applicable regulatory requirements. Be accountable for site performance and delivery of high-quality data within project timelines. Assist Clinical Operations staff and site personnel to resolve issues and implement CAPAs when needed. Verify that Investigator Site Files are maintained according to regulations and company procedures. Support patient recruitment and retention activities. Conduct site visits to ensure compliance with protocol and regulations. Contribute to the internal communication of important clinical data and events. Support the organization of Investigator meetings and study trainings. Serve as a reliable resource for up-to-date site status knowledge for stakeholders. Assist in the implementation of new clinical systems and processes. Collaborate with Investigators, IRBs/ECs, vendors, and internal staff. Comply with all applicable laws, regulations, and company compliance policies. Bachelor's Master's, PhD in Life Sciences, Physical Sciences, Nursing, or Biological Sciences required. Fluency in English, French and Dutch. Previous clinical research experience required. Experience in medical device monitoring (or equivalent) required. Solid understanding of regulations and standards in clinical research and medical devices/combination products. Relevant industry certifications (e.g., CCRA, RAC, CDE) are an asset. Clinical/medical background is a plus. Proficiency in Microsoft Office (Excel, Word, PowerPoint) Jefferson Wells offers you a permanent contrac... PowerPoint, ECS, Medical Devices, Company Procedures, CRA, Delivery, Wellbeing Support, Problem Management, Clinical Research, Life Science, Asset, Law, Regulation, Site Visits, Training, Monitoring, Policy, Nursing, Project Timelines, Company Compliance, Natural science, VOS, Health & Safety, System Process, Life Science, Clinical Research, Patient Support, MS Excel, Clinical Operations, MS Office Suite, Medical Devices, Data acquisition, CAPA, Implementation, Vendors Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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