Description

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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Clinical Research Associate, 60-100% (ID 2117)
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
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 pagacke of social benefits, including supplementary vacation days and pension scheme contributions
Internal skills training opportunities and support for continued education jidb24564fa jit0727a jiy26a