Job Description

About Us:

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.

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.

• 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 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

• Bachelor’s degree is required
• A minimum of 5 years’ experience as a clinical research associate preferred with onsite monitoring and site management activities
• Experience monitoring medical device trials in the 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

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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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