Clinical Research Associate, 60-100% (ID 2117)

pThe AO is a medically guided, not-for-profit organization, a global network of surgeons, and the world's leading education, innovation, and research organization specializing in the surgical treatment of trauma and musculoskeletal disorders. We are home to people from all over the world, from different backgrounds, with diverse talents and specialist areas. What binds us together is our passion for excellence, our dedication to our mission of improving patient care, and our understanding that we are stronger together: we are one AO.br/ For more information, visit: /p pThe streamlines and drives innovation projects. Its activities include the development of clinical solutions with our industrial partner, innovation gathering, proof-of-concept studies, strategic investment in intellectual property, technology, or companies, and evidence creation through clinical research. /p pAs part of the AO ITC, Clinical Operations is the AO’s service provider for clinical research. Our clinical research specialists deliver clinical insights that are highly relevant to current surgical practice and enable better patient care by planning and conducting global clinical trials. /p Employment type / Anstellungsverhältnis: Permanent Workload percentage / Pensum: 100% Location / Standort: p Zizers, CH /p Experience level / gewünschtes Erfahrungsniveau: Experienced professional Application language / Bewerbungssprache: English or German ppbbMain Responsibilities /b /b /p /p liManage clinical studies under scientific and legal guidelines, in collaboration with the project leader /li liPrepare, conduct and follow-up on site evaluation , site initiation, site monitoring, and site close-out of the involved clinics (on-site and remote) /li liAssures adherence to GCP, investigator integrity and compliance with all study procedures through the monitoring phase /li liMake short and long-term plans to monitor involved clinics to ensure data quality and compliance /li liPrepare, develop, and submit documents for public authorities and/or ethics commission submissions /li liDevelop and adapt Case Report Forms (CRFs) /li liControl quality and collection of clinical data /li liUpdate Project Managers regarding the documentation quality of the clinics and report regularly on the general status of the participating site /li liPrepare and implement solutions, in collaboration with the project leader or Head Clinical Operations,to maintain or adapt the project timelines, budget and scope /li liMaintain contact with Principal Investigators and Study Coordinators and provide them support to conduct the clinical investigation /li liConduct regular trainings for study sites to ensure data quality and regulatory compliance within the clinical investigation /li liPrepare and develop Study Newsletters and annual reports as requested by the Project Manager Clinical Operations /li liPrepare clinical data for analysis in collaboration with the project team, including Project Coordinator, Data Manager and Medical Statistician /li liAssist in optimizing quality standards and SOPs /li liPrepare, assist and coordinate contract negotiations /li liThe employee performs all tasks in alignment with the requirements of the ISO 9001 quality management standard and actively contributes to maintaining and improving the quality system /li liThe employee undertakes additional responsibilities and duties as assigned by the line manager to support operational and organizational needs related to the Quality Management System /li ppbbMain Requirements /b /b /p /p pCore Skills/Competencies: /p liStrong communication skills (written and verbal) /li liStructured, detail-oriented working style and reliable documentation /li liAbility to prioritize, manage multiple tasks, and meet deadlines /li liCollaborative team player with a proactive, solution-oriented mindset /li liCan perform assigned tasks independently using guidelines, regulations, and policies /li liSupports the department in achieving its goals /li pEducational Requirements: /p liBachelor in Natural Science, nursing degree /li liFurther education in Clinical Research /li p br/Job Experience: /p liWork experience as a Clinical Research Associate /li liGood market and product knowledge /li liBasic medical knowledge /li liGood understanding of study-related outcome measures /li liExperience with data capture in the field of clinical research /li liStrong organizational and follow-up skills /li liAttention to detail and reliability /li liAbility to work both independently and in a team /li liFlexibility and customer-focused mindset /li pLanguage Skills: /p liStrong written and oral communication skills in English /li p bWe offer /b /p liAn interesting and varied job in an exciting and innovative organization /li liThe opportunity to be part of a highly committed international team /li liModern infrastructure /li liHigh degree of flexibility regarding working hours and location (depending on operational requirements) /li liGenerous package of social benefits, including supplementary vacation days and pension scheme contributions /li liInternal skills training opportunities and support for continued education /li