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

The 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.
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The 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.

As 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.

Employment type / Anstellungsverhältnis: Permanent Workload percentage / Pensum: 100% Location / Standort:

Zizers, CH

Experience level / gewünschtes Erfahrungsniveau: Experienced professional Application language / Bewerbungssprache: English or German

Main Responsibilities

• Manage clinical studies under scientific and legal guidelines, in collaboration with the project leader
• Prepare, conduct and follow-up on site evaluation , site initiation, site monitoring, and site close-out of the involved clinics (on-site and remote)
• Assures adherence to GCP, investigator integrity and compliance with all study procedures through the monitoring phase
• Make short and long-term plans to monitor involved clinics to ensure data quality and compliance
• Prepare, develop, and submit documents for public authorities and/or ethics commission submissions
• Develop and adapt Case Report Forms (CRFs)
• Control quality and collection of clinical data
• Update Project Managers regarding the documentation quality of the clinics and report regularly on the general status of the participating site
• Prepare and implement solutions, in collaboration with the project leader or Head Clinical Operations,to maintain or adapt the project timelines, budget and scope
• Maintain contact with Principal Investigators and Study Coordinators and provide them support to conduct the clinical investigation
• Conduct regular trainings for study sites to ensure data quality and regulatory compliance within the clinical investigation
• Prepare and develop Study Newsletters and annual reports as requested by the Project Manager Clinical Operations
• Prepare clinical data for analysis in collaboration with the project team, including Project Coordinator, Data Manager and Medical Statistician
• Assist in optimizing quality standards and SOPs
• Prepare, assist and coordinate contract negotiations
• The 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
• The employee undertakes additional responsibilities and duties as assigned by the line manager to support operational and organizational needs related to the Quality Management System

Main Requirements

Core Skills/Competencies:

• Strong communication skills (written and verbal)
• Structured, detail-oriented working style and reliable documentation
• Ability to prioritize, manage multiple tasks, and meet deadlines
• Collaborative team player with a proactive, solution-oriented mindset
• Can perform assigned tasks independently using guidelines, regulations, and policies
• Supports the department in achieving its goals

Educational Requirements:

• Bachelor in Natural Science, nursing degree
• Further education in Clinical Research

Job Experience:

• Work experience as a Clinical Research Associate
• Good market and product knowledge
• Basic medical knowledge
• Good understanding of study-related outcome measures
• Experience with data capture in the field of clinical research
• Strong organizational and follow-up skills
• Attention to detail and reliability
• Ability to work both independently and in a team
• Flexibility and customer-focused mindset

Language Skills:

• Strong written and oral communication skills in English

We offer

• An interesting and varied job in an exciting and innovative organization
• The opportunity to be part of a highly committed international team
• Modern infrastructure
• High degree of flexibility regarding working hours and location (depending on operational requirements)
• Generous package of social benefits, including supplementary vacation days and pension scheme contributions
• Internal skills training opportunities and support for continued education