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

The AO is a medically guided, not-for-profit organization, a global network of surgeons, and a leading education, innovation, and research organization specializing in the surgical treatment of trauma and musculoskeletal disorders. The AO Innovation Translation Center (AO ITC) streamlines and drives innovation projects, including clinical solutions development, innovation gathering, proof-of-concept studies, strategic investment, and evidence creation through clinical research. Clinical Operations is the AO’s service provider for clinical research, delivering clinical insights relevant to surgical practice and enabling better patient care by planning and conducting global clinical trials.

• 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 involved clinics (on-site and remote).
• Assure adherence to GCP, investigator integrity, and compliance with all study procedures during 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 documentation quality of clinics and report regularly on the general status of participating sites.
• Prepare and implement solutions, in collaboration with the project leader or Head Clinical Operations, to maintain or adapt project timelines, budget, and scope.
• Maintain contact with Principal Investigators and Study Coordinators and provide support to conduct clinical investigations.
• Conduct regular trainings for study sites to ensure data quality and regulatory compliance within clinical investigations.
• 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.
• Perform all tasks in alignment with ISO 9001 quality management standard requirements and actively contribute to maintaining and improving the quality system.
• Undertake additional responsibilities and duties as assigned by the line manager to support operational and organizational needs related to the Quality Management System.