Clinical Research Associate

Responsibilities

• Select and support preclinical and clinical studies (including patient registries, retro- and prospective studies, case study reviews, pre-clinical technique or biomechanics studies, possible PMA studies, etc.)
• Proactive engagement with study institutions and clinical researchers to participate in studies
• Create new and maintain existing customer contacts to include visits, trainings and advice acting as the point of contact between internal and external partners
• Create new and maintain existing processes within the Medartis quality system ensuring that all processes comply with internal and external regulatory and legal requirements
• Directing communication with the study director from the conception phase until publication of the final report, providing support with writing of study protocols
• Contractual questions and follow up as required
• Implementation of digital tools such as databases, EDC solutions, registries, (e)CRFs, etc. and training of study staff (nurses, PIs, etc.) on said tools
• Supplying study hardware
• Cordination with CROs
• Preparation and maintenance of TMF and ISF
• Support of study site(s) and study nurse(s); e.g., with questions relating to data entry
• Visits and/or on-site monitoring of study sites
• Timely communication with all relevant regulatory bodies/lRBs

Qualifications

• Conscientious, careful, punctual, and reliable work approach
• Fast comprehension and ability to quickly familiarize oneself with new subject areas
• Can work independently and motivated in a small group of specialized experts
• Willingness to take initiative and act autonomously
• Demonstrates assertiveness and patience in daily work
• Relationship development in settings of the field, labs, conferences, or dinner meetings
• Great communication skills
• Bachelor's Degree in a STEM field and ≥2 years' experience at a site, CRO, sponsor, or equivalent professional experience/training required
• Advanced degree preferred
• Familiar with logistical and regulatory issues in the field of clinical studies
• Familiarity with the field of orthopedic surgery or orthopedic medical device design preferred
• Knowledge of statistics is advantageous
• Proficient in office applications
• Familiarity with EDC software solutions is advantageous
• Willingness to travel (up to 20%)
• Fluent (spoken and written) in English, other languages are advantageous