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
Conscientious, careful, punctual, and reliable work approach
Fast comprehension and ability to quickly familiarise 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
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
What we offer 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.
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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
Conscientious, careful, punctual, and reliable work approach
Fast comprehension and ability to quickly familiarise 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
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
What we offer 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.
#J-18808-Ljbffr
Clinical Research Associate Arbeitgeber: Medartis AG
Medartis AG in Basel bietet eine hervorragende Arbeitsumgebung für den Global Total Rewards Specialist: Incentives & Mobility. Mit einem wettbewerbsfähigen Gehalt, einem umfassenden Leistungspaket und einem flexiblen hybriden Arbeitsmodell fördert das Unternehmen eine positive Work-Life-Balance und unterstützt die berufliche Weiterentwicklung seiner Mitarbeiter. Die Unternehmenskultur ist geprägt von Teamarbeit und Innovation, was Medartis zu einem attraktiven Arbeitgeber macht.
