Clinical Research Associate, Selution

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

• 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

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 $66,000 - $82,500 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 ones identity. All our teammates 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.

Preferred Qualifications (Text Only) - 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 $66,000 - $82,500 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 ones identity. All our teammates 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.