The Clinical Research Associate is responsible for the execution, coordination, and oversight of investigator-initiated clinical studies supporting the APTUS product portfolio. This role serves as a key liaison between Medartis, investigators, study sites, and external partners, ensuring studies are conducted in compliance with applicable regulatory requirements, company procedures, and project timelines.
At Medartis, we combine innovative solutions with skilled professionals to be the provider of choice in orthopaedics. Founded in 1997 and headquartered in Basel, Switzerland, the Medartis Group is one of the world's leading manufacturers and providers of medical devices for the surgical fixation of bone fractures in the upper and lower extremities, as well as the craniomaxillofacial region. The company employs around 1,400 people across its 13 locations and sells its products in over 50 countries worldwide.
Your 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
- Coordination 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
Your 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
This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.
For further information please visit our Website www.medartis.com.
We look forward to receiving your complete online application.
Medartis
Human Resources
T +1 610 961 6101
www.medartis.com