Job Location : Irvine,CA, USA
Overview
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.
Responsibilities
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 in 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 Selution, 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 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 reviews of site study documentation (e.g. ICFs, CTAs, budgets) to managers and study sites
Study eTMF audit readiness
Site management
Qualifications
Minimum 3 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
Preferred Qualifications
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
Pay / Compensation
The expected pre-tax pay rate for this position is $76,450 - $102,300 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.
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Job Locations US-CA-Irvine
ID 2025-9222
Category Clinical
Position Type Regular Full-Time
CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact ...@Cordis.com