Clinical Research Associate, Coronary- Ous

vor 2 Wochen

Frankfurt am Main, Deutschland Cordis Vollzeit

Overview:
MedAlliance, 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. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is the place for you. Join us, and let’s improve the wellbeing of millions, together. We are the people behind the people who keep saving lives.

We are seeking a Clinical Research Associate to join our 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 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
- Study eTMF, audit readiness, and site management

Qualifications:

- 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.
- Plus, but not required: Experience with coronary clinical studies.
- Fluent in English
- Required: A minimum of a Bachelor’s degree.
- Attention to detail and accuracy of output
- Has a track record of operating independently
- Skill in prioritizing workflow to meet deadlines
- Capable of working across multiple time zones including US and Asia

Pay / Compensation

The expected pre-tax pay rate for this position is $81,000 - $101,000 CHF

Actual pay may fluctuate outside of the range depending on skills, education, experience, job-related knowledge and location.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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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