Website Cordis
Cordis
Company : Cordis
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:
We are seeking a Clinical Trial Associate to join our clinical study team in the peripheral/coronary space to help 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.
Key Accountabilities
- Support study sites and activities to ensure adherence to appropriate industry US and OUS regulations, compliance with the study Protocol(s), and applicable local regulations
- Assist in coordination of study tasks from start-up phase through study completion
- Maintain internal Trial Master Files (TMFs) and prepare study TMF for audit readiness
- Assist in organizing Steering Committee events and meetings
- 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 preparation for Investigator meetings and Study Coordinator meetings
- Ensure proper escalation of site/project related issues to the Study Lead in a timely manner
- Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
- Assist with device accountability
- Support internal audit preparation
- Collect and file site study documentation (e.g. ICFs, CTAs, budgets)
Qualifications:
- Required:A minimum of a Bachelor’s degree.
- At least 1-2 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
Preferred Qualifications:
- 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
- Plus, but not required:Experience working on an IDE clinical study
- Plus, but not required:Experience with coronary/peripheral clinical studies
Pay / Compensation
The expected pre-tax pay rate for this position is $73,500 – $92,000 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.
Preferred Qualifications (Text Only):
– 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
– Plus, but not required:Experience working on an IDE clinical study
– Plus, but not required:Experience with coronary/peripheral clinical studies
Pay / Compensation
The expected pre-tax pay rate for this position is $73,500 – $92,000 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.