Website Cordis
Cordis
Company : Cordis
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.
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.
Responsibilities:
In this role, you will be participating on a clinical study team to support the execution of both pre-market and post-market clinical trials in the cardiovascular space, thereby giving you the opportunity to be directly involved in the success of the organization in improving patient care. You will perform various duties and responsibilities as directed by the clinical study leader. In this role, you will assist in organizing and executing remote monitoring and/or onsite monitoring for the different stages of clinical trials. You will interact with healthcare professionals and with internal project teams. Details of the Function:· Serve as the primary point of contact for assigned sites, providing guidance on protocol requirements, operational workflows, and issue resolution· Supervise study sites and activities to ensure adherence to appropriate industry US and OUS regulations, ICH/GCP, the study Protocol(s), and applicable local regulations.· Conduct remote and/or onsite qualification, initiation, interim monitoring, and close‑out visits with minimal oversight.
- Perform and communicate detailed review of site study documentation (e.g. ICFs, CTAs, budgets), site-reported data, etc. to Study Lead and study sites.
· Lead or assist with preparation of study documents (study protocol, ICF, CRF, etc.) and study plans. · 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.· Assess site performance, enrollment progress, and protocol compliance; implement corrective and preventive actions (CAPAs) when needed.· Prepare dashboards, reports and other internal tracking mechanisms. · Collaborate with cross‑functional teams (clinical operations, data management, safety, regulatory) to ensure timely study execution.· Work with and/or oversee the CRO and Core Labs to ensure study operations and activities are of high quality.
- Assist with organization and content preparation for Investigator meetings and Study Coordinator meetings.
- Ensure proper proactive and timely escalation of site/project related issues and risks to the Study Lead and contribute to mitigation strategies.
- Assist with internal audit preparation.
- Support sites in preparing for audits and inspections; participate in sponsor or regulatory authority inspections as needed.
- Provide coaching, oversight, and co‑monitoring support to any junior CRAs.
- Contribute to process improvement initiatives, SOP updates, and operational best practices.
Key Accountabilities
- Study eTMF audit readiness
- Site management
Key Interactions
- Role reports to Clinical Affairs Manager
Qualifications:
Required Qualifications
Requires a minimum 5+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; Or 3+ years and a Master's degree;Or a PhD with no previous professional experience.Where required, the role must hold an appropriate degree in the industry (eg. Legal)
Preferred 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/GCP guidelines, FDA regulations and clinical trial operations
- Plus, but not required: Experience working on an IDE clinical study
- Plus, but not required: Experience with cardiovascular clinical studies
- Required: A minimum of a Bachelor’s degree, preferably in life sciences, nursing, pharmacy or related field.
Competencies & Skills
- Strong work ethics and commitment to serve internal and external clients.
- Energy, focus, motivation, debate-friendly, and good interpersonal skills
- Strong analytical and problem‑solving skills with the ability to anticipate site‑level risks
- Open and honest approach to debates and constant evaluation.
- Team player, “can-do” attitude
- Ability and desire to develop good working relationships internally and externally
- Excellent written and verbal communication and documentation skills
- Proficiency in English to enable engagement with global clinicians
- Attention to detail and accuracy of output
- Enjoys and has a track record of operating independently and with minimal supervision
- Skill in project management, managing multiple sites and prioritizing workflow to meet deadlines
- Capable of working across multiple time zones including Europe
- Proficiency with MS software (Word, Excel, Powerpoint), EDC, CTMS, eTMF
Physical Requirements
- Must be able to travel up to 10-20%
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.