Clinical Research Associate. Coronary - OUS (Selution)
Clinical Research Associate. Coronary - OUS (Selution)
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Overview
When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.
Overview
When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.
Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.
At Cordis, we’re teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.
If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.
The Clinical Research Associate (Coronary) role is a key position within the coronary program to help ensure FDA clearance through a PMA approval of this innovative device is granted and patients have access to this device.
In this role, you will be participating on a clinical study team in the coronary space to execute a randomized, multi-center IDE clinical trial. You will perform various duties and responsibilities as directed by the clinical study leader. This research is the top priority for MedAlliance, giving you the opportunity to be directly involved in the success of the organization in improving patient care. In this role, you will assist in organizing and monitoring the different stages of clinical trials. You will interact with healthcare professionals and with internal project teams.
Responsibilities
* Supervise study sites and activities to ensure adherence to appropriate industry US and OUS regulations, compliance with the study Protocol(s), and applicable local regulations
* Manage and maintain internal Trial Master Files (TMFs). Potentially develop a standardized eTMF file nomenclature so that all files are consistently named
* Assist in organizing Steering Committee events and meetings, along with helping to prepare educational content
* Prepare dashboards, reports and other internal tracking mechanisms
* Work with the CRO and Core Labs to ensure study operations and activities are of a high quality
* Assist with organization and content preparation for Investigator meetings and Study Coordinator meetings
* Ensure proper escalation of site/project related issues to the Study Lead in a timely manner
* Assist with internal audit preparation
* Provide and communicate detailed review of site study documentation (e.g. ICFs, CTAs, budgets) to manager and study sites
* Key Accountabilities
* Study eTMF audit readiness
* Site management
Qualifications
* At least 3-5 years of experience working in the medical device space in a CRO or Sponsor setting with strong knowledge of conducting studies under ICH and GCP guidelines
* Bachelor's degree, required
* Plus, but not required: Experience working on an IDE clinical study
* Plus, but not required: Experience with coronary/cardiac clinical studies
Competencies & Skills
* Attention to detail and accuracy of output
* Ability to communicate efficiently and effectively with investigators, site research staff and co-workers
* High energy
* Enjoys and has a track record of operating independently
* Skill in prioritizing workflow to meet deadlines
* Capable of working across multiple time zones including Europe
* Fluent in English
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Analyst, and Information Technology
* Industries
Medical Equipment Manufacturing
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