Senior Clinical Research Associate - EU (Medical Devices)
Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.
Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV, incorporating our proprietary ADAPT® anti‑calcification technology to mimic the natural function of a healthy heart valve.
Key Responsibilities
* Oversee CRO and vendor activities, while also directly contributing to study start‑up and conduct activities (e.g., site‑specific ICF review, essential document review, progress tracking).
* Conduct site initiation and (co)-monitoring visits; train and support site personnel on sponsor and regulatory requirements; lead or participate in investigator meetings; prepare or review detailed visit reports and documentation.
* Serve as sponsor liaison for assigned research institutions, providing guidance and support to research teams from study start‑up through close‑out.
* Verify accuracy and completeness of clinical data, source documentation, and regulatory files, ensuring compliance with study protocols, SOPs, GCP, GDPR, local and global regulations.
* Identify, investigate, and resolve discrepancies in study documentation; implement corrective and preventive actions to reduce recurrence.
* Review and maintain Trial Master File (TMF) documentation for audit readiness; ensure alignment with Good Documentation Practices and regulatory expectations (e.g., FDA, ISO14155, EU‑MDR).
* Partner with cross‑functional teams to support site activation, enrollment progress, and data cleaning in alignment with study timelines.
Required Skills, Knowledge, and Experience
* Bachelor’s degree in a scientific or health‑related field.
* 5+ years of clinical site management experience, including prior field monitoring experience.
* Strong background in medical devices required; Class III cardiovascular device experience highly preferred.
* Experience collaborating with CROs, core labs, and external vendors.
* Prior involvement in site‑ and sponsor‑level regulatory agency audits (FDA or BIMO experience a plus).
* Strong written and verbal communication skills, with the ability to present clearly to varied audiences.
* Experience in a Cardiac Cath Lab setting highly preferred.
* Demonstrated problem‑solving, critical‑thinking, and organizational skills, with keen attention to detail.
* Proficiency with MS Office Suite, Adobe, and EDC platforms (e.g., Medidata RAVE, Viedoc); working knowledge of CTMS and eTMF systems.
* Thorough knowledge of GCP, FDA, ISO14155, and other relevant regulatory frameworks.
* Clinical research certification (ACRP or SOCRA, CRA/Coordinator certification) preferred.
* Ability to travel up to 50% during activation and early enrollment; 30% otherwise across Europe.
* Fluent in spoken and written English required. Preference given to qualified candidates with fluency in French and German. Other EU languages (e.g. Dutch, Danish) a plus.
What We Offer
* Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
* Collaborative and dynamic work environment with a culture of innovation and excellence.
* Competitive compensation package, including salary and performance‑based bonus.
* Career development opportunities and a chance to be part of a growing company that values its employees.
Note: We may require proof of COVID‑19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.
Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturalism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment – it is part of our mission to deliver the best structural heart products on a global scale.
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