With more than a 60-year history of pioneering products to treat millions of patients, Cordis is a worldwide leader in the development and manufacturing of interventional cardiovascular technology. Cordis established a legacy of high-quality and minimally-invasive cardiovascular products; and has built a robust global footprint with operations in more than 60 countries around the world. As of August 2, 2021, Cordis is an independent company and is committed to investing $300 million to accelerate innovation and broaden its product portfolio offering. Building on our storied brand, we are unleashing our potential to be a 10X valued leader bringing new technology to the market through bold action at speed.

Manufacturing & Electronics

Cordis

You need a relevant Bachelor’s or be enrolled in an engineering program, CAD proficiency in Solid Works, and coursework in stats for data analysis.

You will apply engineering knowledge to design and test medical devices, develop solutions, analyze data, and collaborate with engineers on production processes.

Engineering

Healthcare

Santa Clara

<div>Overview:
<div><b>
About Us: </b>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.</div><div></div><div><br>
At Cordis, we&rsquo;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.</div><div></div><div><br>
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.</div><div></div><div><b><br>
We are the people behind the people who keep saving lives.</b></div><br>
<div></div>
Responsibilities:
<ul><li>Applies comprehensive medical device engineering knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects</li><li>
May contribute to the development of policies and procedures.</li><li>
Works on complex projects of small / medium scope.</li><li>
Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.</li><li>
Completes work independently receives general guidance on new projects</li><li>
Supports test method development and implementation activities to support design validation and usability testing.</li><li>
Executes validation and usability testing per protocols. Conducts analysis of testing data and generates reports.</li><li>
Ensures design solutions are documented, evaluated against design input, and tested properly.</li><li>
Works on the design of devices and components assigned as an individual technical contributor.</li><li>
Works closely with manufacturing engineers on process development for mass production of medical devices.</li></ul>
Qualifications:<br>
<p></p><ul><li>
Bachelor&rsquo;s degree in Biomedical Engineering, Mechanical Engineering, or currently enrolled in an engineering program at an accredited university</li><li>
Coursework on mechanical or biomedical engineering.</li><li>
Proficiency in Computer-Aided Design (CAD), properly using Solid Works.</li><li>
Spreadsheet operations and data analysis capability with completed coursework on statistics</li></ul><div></div><div><br>
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&rsquo;s identity. All our teammate&rsquo;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.</div></div>

Overview:

About Us: 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:
Applies comprehensive medical device engineering knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
May contribute to the development of policies and procedures.
Works on complex projects of small / medium scope.
Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.
Completes work independently receives general guidance on new projects
Supports test method development and implementation activities to support design validation and usability testing.
Executes validation and usability testing per protocols. Conducts analysis of testing data and generates reports.
Ensures design solutions are documented, evaluated against design input, and tested properly.
Works on the design of devices and components assigned as an individual technical contributor.
Works closely with manufacturing engineers on process development for mass production of medical devices.
Qualifications:

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or currently enrolled in an engineering program at an accredited university
Coursework on mechanical or biomedical engineering.
Proficiency in Computer-Aided Design (CAD), properly using Solid Works.
Spreadsheet operations and data analysis capability with completed coursework on statistics
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.

Intern, Research and Development (US) - Cordis

Intern, Research and Development (US)

You should embrace diversity and inclusion in the workplace, with a passion for finance and a willingness to learn in a part-time role.

You will assist with financial analysis, support budgeting processes, and contribute to financial reporting while promoting diversity and inclusion within the workplace.

Customer Relations

People, HR & Administration

Miami Lakes

<b>Qualifications:</b><br>
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.

Qualifications:
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.

Finance Intern (Part-Time) - Cordis

<b>Qualifications:</b><br> 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.

Finance Intern (Part-Time)

You need a Bachelor’s in Life Sciences or related field, 3 years in medical device support, strong cardiology knowledge, and excellent communication skills. Frequent travel and clinical presence required.

You will provide technical support, educate healthcare providers, conduct training, build relationships, identify opportunities, and gather market insights to enhance product usage and drive sales.

Product

Rome

<div>Overview:
<div>
At Cordis, we aim to be a trusted partner, offering a broad range of innovative solutions that help our customers provide cost-efficient, more effective healthcare. Our focus is on cardiac and endovascular platforms. We offer high quality products such as diagnostic and interventional catheters, balloons, drug-eluting and self-expanding stents, guidewires and products to stop vascular bleeding. In collaboration with our customers, we develop solutions that achieve the best possible outcomes for physicians and patients.</div><div>
We are currently looking for a Field Product Specialist in the North of Italy (preferably in Lombardia, Veneto or Emilia Romagna), who will be working both remotely and in the field.</div><div>
The Field Product Specialist is a key role responsible for driving the adoption, utilization, and sales of DCB and other products, in particular Selution SLR, within assigned territories. This individual will act as the product expert, providing technical and clinical support to healthcare professionals, collaborating with sales teams to achieve revenue targets, and ensuring that the organization's portfolio is positioned as the standard of care in peripheral and/or coronary interventions.</div>
Responsibilities:<div></div><div><br>
 1. Clinical and Technical Support</div><ul><li>
Serve as the primary resource for technical expertise on Cordis products, with a focus on DCB technology.</li><li>
Provide in-field support to interventionalists, surgeons, and cath lab teams, ensuring optimal product usage.</li><li>
Educate healthcare providers on the clinical benefits and proper application of Selution SLR through presentations, case observations, and hands-on training.</li><li>
Stay informed on the latest clinical evidence, guidelines, and competitive landscape to address customer questions confidently.</li><li><div>
</div></li><li>
Sales Support</li></ul><ul><li>
Collaborate with the sales team to identify opportunities, develop strategies, and execute plans to achieve sales objectives.
</li><li>Assist in product demonstrations customer sites.
</li><li>Build and maintain strong relationships with key opinion leaders (KOLs), physicians, and decision-makers.
</li><li>Partner with sales representatives to provide insights that align with customer needs and market demands.
</li><li>Training and Education</li></ul><ul><li>
Conduct product training sessions for internal teams and external stakeholders, including physicians, nurses, and other healthcare professionals.
</li><li>Participate in workshops, symposia, and conferences to promote DCB technology and build brand awareness.
</li><li>Act as a liaison between the clinical, marketing, and sales teams to ensure consistent messaging and alignment of objectives.</li><li>
Market Development</li></ul><ul><li>
Identify and develop new business opportunities within the territory, targeting accounts and clinicians not currently utilizing Selution SLR.</li><li>
Gather feedback from the field to inform product development, marketing strategies, and competitive positioning.
</li><li>Monitor market trends, reimbursement changes, and competitor activity, reporting findings to relevant teams.
</li></ul>Qualifications:
<div><b>
Education</b></div><ul><li>
Bachelor&rsquo;s degree in Life Sciences, Biomedical Engineering, or a related field.
</li><li>Advanced degrees or certifications in healthcare (e.g., nursing, radiology, or cardiovascular technology) are a plus.
</li></ul><div><b>Experience</b></div><ul><li>
Minimum 3 years of experience in a clinical, technical, or sales support role within the medical device or healthcare industry.
</li><li>Strong knowledge of interventional cardiology, vascular surgery, or related fields is highly desirable.
</li><li>Proven experience supporting products in a cath lab or operating room setting is preferred.</li></ul><div><br>
</div><div><b>Skills and Competencies</b></div><ul><li>
Exceptional communication and interpersonal skills, with the ability to build trust with healthcare professionals and internal teams.
</li><li>Strong technical acumen and ability to simplify complex concepts for diverse audiences.
</li><li>Results-oriented mindset with demonstrated ability to achieve sales and market development goals.
</li><li>Highly organized, self-motivated, and able to work independently in a fast-paced environment.
</li><li>Proficiency with CRM systems, Microsoft Office Suite, and virtual training platforms.</li><li>
Extensive travel required within assigned territory, with occasional overnight stays.
</li><li>Availability to attend early morning or evening procedures and training sessions as needed.
</li><li>This role involves frequent presence in clinical settings, including cath labs, operating rooms, and hospitals.</li></ul><div><br>
</div><div>This position is ideal for a dynamic, technically skilled professional passionate about advancing innovative solutions in vascular and cardiovascular interventions. If you&rsquo;re ready to make a significant impact in the field, we&rsquo;d love to hear from you.
</div><div>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&rsquo;s identity. All our teammate&rsquo;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.</div></div>

Overview:

At Cordis, we aim to be a trusted partner, offering a broad range of innovative solutions that help our customers provide cost-efficient, more effective healthcare. Our focus is on cardiac and endovascular platforms. We offer high quality products such as diagnostic and interventional catheters, balloons, drug-eluting and self-expanding stents, guidewires and products to stop vascular bleeding. In collaboration with our customers, we develop solutions that achieve the best possible outcomes for physicians and patients.
We are currently looking for a Field Product Specialist in the North of Italy (preferably in Lombardia, Veneto or Emilia Romagna), who will be working both remotely and in the field.
The Field Product Specialist is a key role responsible for driving the adoption, utilization, and sales of DCB and other products, in particular Selution SLR, within assigned territories. This individual will act as the product expert, providing technical and clinical support to healthcare professionals, collaborating with sales teams to achieve revenue targets, and ensuring that the organization's portfolio is positioned as the standard of care in peripheral and/or coronary interventions.
Responsibilities:
 1. Clinical and Technical Support
Serve as the primary resource for technical expertise on Cordis products, with a focus on DCB technology.
Provide in-field support to interventionalists, surgeons, and cath lab teams, ensuring optimal product usage.
Educate healthcare providers on the clinical benefits and proper application of Selution SLR through presentations, case observations, and hands-on training.
Stay informed on the latest clinical evidence, guidelines, and competitive landscape to address customer questions confidently.

Sales Support
Collaborate with the sales team to identify opportunities, develop strategies, and execute plans to achieve sales objectives.
Assist in product demonstrations customer sites.
Build and maintain strong relationships with key opinion leaders (KOLs), physicians, and decision-makers.
Partner with sales representatives to provide insights that align with customer needs and market demands.
Training and Education
Conduct product training sessions for internal teams and external stakeholders, including physicians, nurses, and other healthcare professionals.
Participate in workshops, symposia, and conferences to promote DCB technology and build brand awareness.
Act as a liaison between the clinical, marketing, and sales teams to ensure consistent messaging and alignment of objectives.
Market Development
Identify and develop new business opportunities within the territory, targeting accounts and clinicians not currently utilizing Selution SLR.
Gather feedback from the field to inform product development, marketing strategies, and competitive positioning.
Monitor market trends, reimbursement changes, and competitor activity, reporting findings to relevant teams.
Qualifications:

Education
Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field.
Advanced degrees or certifications in healthcare (e.g., nursing, radiology, or cardiovascular technology) are a plus.
Experience
Minimum 3 years of experience in a clinical, technical, or sales support role within the medical device or healthcare industry.
Strong knowledge of interventional cardiology, vascular surgery, or related fields is highly desirable.
Proven experience supporting products in a cath lab or operating room setting is preferred.
Skills and Competencies
Exceptional communication and interpersonal skills, with the ability to build trust with healthcare professionals and internal teams.
Strong technical acumen and ability to simplify complex concepts for diverse audiences.
Results-oriented mindset with demonstrated ability to achieve sales and market development goals.
Highly organized, self-motivated, and able to work independently in a fast-paced environment.
Proficiency with CRM systems, Microsoft Office Suite, and virtual training platforms.
Extensive travel required within assigned territory, with occasional overnight stays.
Availability to attend early morning or evening procedures and training sessions as needed.
This role involves frequent presence in clinical settings, including cath labs, operating rooms, and hospitals.
This position is ideal for a dynamic, technically skilled professional passionate about advancing innovative solutions in vascular and cardiovascular interventions. If you’re ready to make a significant impact in the field, we’d love to hear from you.
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.

Field Product Specialist - North Italy (Lombardia - Veneto - Emilia Romagna) - Cordis

Italy

<div>
 Overview: 
 <div>
  At Cordis, we aim to be a trusted partner, offering a broad range of innovative solutions that help our customers provide cost-efficient, more effective healthcare. Our focus is on cardiac and endovascular platforms. We offer high quality products such as diagnostic and interventional catheters, balloons, drug-eluting and self-expanding stents, guidewires and products to stop vascular bleeding. In collaboration with our customers, we develop solutions that achieve the best possible outcomes for physicians and patients.
 </div>
 <div>
  We are currently looking for a Field Product Specialist in the North of Italy (preferably in Lombardia, Veneto or Emilia Romagna), who will be working both remotely and in the field.
 </div>
 <div>
  The Field Product Specialist is a key role responsible for driving the adoption, utilization, and sales of DCB and other products, in particular Selution SLR, within assigned territories. This individual will act as the product expert, providing technical and clinical support to healthcare professionals, collaborating with sales teams to achieve revenue targets, and ensuring that the organization's portfolio is positioned as the standard of care in peripheral and/or coronary interventions.
 </div> Responsibilities:
 <div></div>
 <div>
  <br> 1. Clinical and Technical Support
 </div>
 <ul>
  <li>Serve as the primary resource for technical expertise on Cordis products, with a focus on DCB technology.</li>
  <li>Provide in-field support to interventionalists, surgeons, and cath lab teams, ensuring optimal product usage.</li>
  <li>Educate healthcare providers on the clinical benefits and proper application of Selution SLR through presentations, case observations, and hands-on training.</li>
  <li>Stay informed on the latest clinical evidence, guidelines, and competitive landscape to address customer questions confidently.</li>
  <li>
   <div>
   </div></li>
  <li>Sales Support</li>
 </ul>
 <ul>
  <li>Collaborate with the sales team to identify opportunities, develop strategies, and execute plans to achieve sales objectives.</li>
  <li>Assist in product demonstrations customer sites.</li>
  <li>Build and maintain strong relationships with key opinion leaders (KOLs), physicians, and decision-makers.</li>
  <li>Partner with sales representatives to provide insights that align with customer needs and market demands.</li>
  <li>Training and Education</li>
 </ul>
 <ul>
  <li>Conduct product training sessions for internal teams and external stakeholders, including physicians, nurses, and other healthcare professionals.</li>
  <li>Participate in workshops, symposia, and conferences to promote DCB technology and build brand awareness.</li>
  <li>Act as a liaison between the clinical, marketing, and sales teams to ensure consistent messaging and alignment of objectives.</li>
  <li>Market Development</li>
 </ul>
 <ul>
  <li>Identify and develop new business opportunities within the territory, targeting accounts and clinicians not currently utilizing Selution SLR.</li>
  <li>Gather feedback from the field to inform product development, marketing strategies, and competitive positioning.</li>
  <li>Monitor market trends, reimbursement changes, and competitor activity, reporting findings to relevant teams.</li>
 </ul>Qualifications: 
 <div>
  <b> Education</b>
 </div>
 <ul>
  <li>Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field.</li>
  <li>Advanced degrees or certifications in healthcare (e.g., nursing, radiology, or cardiovascular technology) are a plus.</li>
 </ul>
 <div>
  <b>Experience</b>
 </div>
 <ul>
  <li>Minimum 3 years of experience in a clinical, technical, or sales support role within the medical device or healthcare industry.</li>
  <li>Strong knowledge of interventional cardiology, vascular surgery, or related fields is highly desirable.</li>
  <li>Proven experience supporting products in a cath lab or operating room setting is preferred.</li>
 </ul>
 <div>
  <br>
 </div>
 <div>
  <b>Skills and Competencies</b>
 </div>
 <ul>
  <li>Exceptional communication and interpersonal skills, with the ability to build trust with healthcare professionals and internal teams.</li>
  <li>Strong technical acumen and ability to simplify complex concepts for diverse audiences.</li>
  <li>Results-oriented mindset with demonstrated ability to achieve sales and market development goals.</li>
  <li>Highly organized, self-motivated, and able to work independently in a fast-paced environment.</li>
  <li>Proficiency with CRM systems, Microsoft Office Suite, and virtual training platforms.</li>
  <li>Extensive travel required within assigned territory, with occasional overnight stays.</li>
  <li>Availability to attend early morning or evening procedures and training sessions as needed.</li>
  <li>This role involves frequent presence in clinical settings, including cath labs, operating rooms, and hospitals.</li>
 </ul>
 <div>
  <br>
 </div>
 <div>
  This position is ideal for a dynamic, technically skilled professional passionate about advancing innovative solutions in vascular and cardiovascular interventions. If you’re ready to make a significant impact in the field, we’d love to hear from you.
 </div>
 <div>
  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.
 </div>
</div>

Field Product Specialist - North Italy (Lombardia - Veneto - Emilia Romagna)

You need a bachelor’s degree, 5+ years as a CRA, medical device monitoring experience, strong computer skills, detail-oriented, fluent in English, and excellent interpersonal and problem-solving abilities.

You will manage trial sites, ensure compliance with protocols, verify safety reporting, support recruitment, maintain data integrity, and assist in audit readiness and training activities.

Madrid

<div>Overview:
<p>
Cordis is a pioneering medical technology company specializing in groundbreaking solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.</p><p></p><p><br>
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&rsquo;s improve the wellbeing of millions, together.</p><p></p><p><br>
We are the people behind the people who keep saving lives.</p><div></div><div><br>
The Clinical Research Associate (CRA) reports to the Clinical Monitoring Manager. The CRA is responsible for the initiation, maintenance and closure of trial sites. The CRA will ensure that the trial data is accurate, complete, and that the trial is conducted in accordance with protocol requirements, laboratory collections, imaging collections, regulatory requirements. The CRA will ensure relevant clinical research guidelines are adhered to and that project timelines are met. This role will interact with the clinical team, cross-functional internal teams, clinical vendors and with healthcare professionals. Clinical research is the top priority for Cordis, and this role will be directly involved in the success of the organization in improving patient care.
</div>Responsibilities:
<div><b>
Key Accountabilities</b>
<br>
<ul><li>Accountable for the initiation, maintenance and closure of assigned trial sites
</li><li>The CRA will ensure consistent support is provided to trial sites
</li><li>Verifies safety reporting, monitoring, storage of investigational device according to study specifications, regulatory agency requirements, Cordis SOPs, ICH-GCP Guidelines, ISO 14155
</li><li>Ensure accuracy, validity, and completeness of data at trial sites in compliance with the protocol, clinical monitoring plan, informed consent forms and associated trial documents.
</li><li>Responsible for investigational device accountability/reconciliation and ensure any discrepancies, expirations or technical issues are addressed
</li><li>Ensure trial deliverables are met with efficiency and quality
</li><li>Ensure trial sites are trained and associated training documentation is available in the site&rsquo;s investigator file and sponsor trial master file
</li><li>Support clinical trial site setup and activation activities
</li><li>May contribute to the development and review of the Clinical Monitoring Plan, monitoring tools, and training materials as needed
</li><li>Assist in the development of CRFs and edit checks
</li><li>Drives recruitment and retention strategies to support clinical trial enrollment/retention milestones
</li><li>Manage assigned sites to ensure monitoring metrics are met per the Clinical Monitoring Plan
</li><li>Ensuring the Trial Master File is maintained and ready for inspection
</li><li>Provide insights into trial activities, such as trends in enrollment, protocol compliance, and data quality and escalate site issues to the study team
</li><li>Assist with resolving issues that have been identified, including actions to prevent reoccurrences
</li><li>Participates in study specific meetings, teleconferences and trainings
</li><li>Ensure monitoring timelines are on track for each of the studies in relation to the PMA submission timelines
</li><li>Supports the preparation, conduct and follow-up of BIMO audit readiness in relation to monitoring of the IDE trials
</li><li>May be responsible for co-monitoring as needed<br>
</li></ul><br>
<br>
<b>Key Interactions</b><br>
<ul><li>Key interactions with clinical leadership (e.g. Monitoring Manager, Sr. Dir Clinical Operations, SVP Clinical &amp; Regulatory), study leaders and managers, CRAs, physicians and site personnel, CROs, and outside vendors</li></ul></div>
Qualifications:
<ul><li>Bachelor&rsquo;s degree is required
</li><li>A minimum of 5 years&rsquo; experience as a clinical research associate preferred with onsite monitoring and site management activities
</li><li>Required knowledge and experience monitoring medical device trials and cardiovascular space
</li><li>Demonstrates proficiency with computer skills (MS Office, Word, Excel and PowerPoint)
</li><li>Travel is required (Approx 50%) May vary to meet trial milestones</li></ul><div><br>
</div><div><b>Competencies &amp; Skills
</b><br>
<ul><li>Detail-Oriented
</li><li>Ability to support and inspire site personnel
</li><li>Strong written and oral communication skills
</li><li>Highly organized, outcome-oriented, self-motivated performance
</li><li>Supportive, keen to promote quality through example and continuous support.
</li><li>Critical-thinking and problem-solving skills
</li><li>Ability to make independent decisions
</li><li>Excellent interpersonal skills &ndash; ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
</li><li>Skill in prioritizing workflow to meet deadlines
</li><li>Fluent in English</li></ul></div></div>

Overview:

Cordis is a pioneering medical technology company specializing in groundbreaking solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.
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.
The Clinical Research Associate (CRA) reports to the Clinical Monitoring Manager. The CRA is responsible for the initiation, maintenance and closure of trial sites. The CRA will ensure that the trial data is accurate, complete, and that the trial is conducted in accordance with protocol requirements, laboratory collections, imaging collections, regulatory requirements. The CRA will ensure relevant clinical research guidelines are adhered to and that project timelines are met. This role will interact with the clinical team, cross-functional internal teams, clinical vendors and with healthcare professionals. Clinical research is the top priority for Cordis, and this role will be directly involved in the success of the organization in improving patient care.
Responsibilities:

Key Accountabilities

Accountable for the initiation, maintenance and closure of assigned trial sites
The CRA will ensure consistent support is provided to trial sites
Verifies safety reporting, monitoring, storage of investigational device according to study specifications, regulatory agency requirements, Cordis SOPs, ICH-GCP Guidelines, ISO 14155
Ensure accuracy, validity, and completeness of data at trial sites in compliance with the protocol, clinical monitoring plan, informed consent forms and associated trial documents.
Responsible for investigational device accountability/reconciliation and ensure any discrepancies, expirations or technical issues are addressed
Ensure trial deliverables are met with efficiency and quality
Ensure trial sites are trained and associated training documentation is available in the site’s investigator file and sponsor trial master file
Support clinical trial site setup and activation activities
May contribute to the development and review of the Clinical Monitoring Plan, monitoring tools, and training materials as needed
Assist in the development of CRFs and edit checks
Drives recruitment and retention strategies to support clinical trial enrollment/retention milestones
Manage assigned sites to ensure monitoring metrics are met per the Clinical Monitoring Plan
Ensuring the Trial Master File is maintained and ready for inspection
Provide insights into trial activities, such as trends in enrollment, protocol compliance, and data quality and escalate site issues to the study team
Assist with resolving issues that have been identified, including actions to prevent reoccurrences
Participates in study specific meetings, teleconferences and trainings
Ensure monitoring timelines are on track for each of the studies in relation to the PMA submission timelines
Supports the preparation, conduct and follow-up of BIMO audit readiness in relation to monitoring of the IDE trials
May be responsible for co-monitoring as needed


Key Interactions
Key interactions with clinical leadership (e.g. Monitoring Manager, Sr. Dir Clinical Operations, SVP Clinical & Regulatory), study leaders and managers, CRAs, physicians and site personnel, CROs, and outside vendors
Qualifications:
Bachelor’s degree is required
A minimum of 5 years’ experience as a clinical research associate preferred with onsite monitoring and site management activities
Required knowledge and experience monitoring medical device trials and cardiovascular space
Demonstrates proficiency with computer skills (MS Office, Word, Excel and PowerPoint)
Travel is required (Approx 50%) May vary to meet trial milestones
Competencies & Skills

Detail-Oriented
Ability to support and inspire site personnel
Strong written and oral communication skills
Highly organized, outcome-oriented, self-motivated performance
Supportive, keen to promote quality through example and continuous support.
Critical-thinking and problem-solving skills
Ability to make independent decisions
Excellent interpersonal skills – ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
Skill in prioritizing workflow to meet deadlines
Fluent in English

Cordis

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