Note: The job is a remote job and is open to candidates in USA. Medartis is a company focused on clinical research, and they are seeking a Clinical Research Associate. The role involves selecting and supporting clinical studies, engaging with study institutions, and ensuring compliance with regulatory requirements.
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
- Responsible for the complete development of study protocols that meet FDA clearance standards, maintain the continuum of support documentation to further validate the proper ‘Indications for Use’ via education and training on the future and existing Medartis product offerings
- Execute investigator-initiated studies for APTUS
- Intake and evaluation of new studies
- Contract and invoice management, open payments
- Final report review
- Notifications to stakeholders
Skills
- 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
- Familiar with logistical and regulatory issues in the field of clinical studies
- Proficient in office applications
- Willingness to travel (up to 20%)
- Fluent (spoken and written) in English
- Advanced degree preferred
- Familiarity with the field of orthopedic surgery or orthopedic medical device design preferred
- Knowledge of statistics is advantageous
- Familiarity with EDC software solutions is advantageous
- Other languages are advantageous
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