Job Description
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. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world's first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.
The Sr. Clinical Research Associate (CRA) will play a key role in the execution of our global pivotal trial, ensuring the highest standards of quality and compliance. This role combines vendor / CRA oversight with budget and agreement negotiation and site activation oversight, direct clinical monitoring and auditing responsibilities, including site visits to verify data accuracy, assess patient safety, and confirm site compliance with regulatory requirements.
At Anteris® Technologies, you'll join a team committed to improving the lives of patients with aortic stenosis through groundbreaking structural heart solutions. This is an opportunity to make a measurable impact on patient outcomes while shaping the future of heart valve innovation.
Preferred Locations: Remote, US
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 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, PHI, and global regulations.
- Identify, investigate, and resolve discrepancies in study documentation; implement corrective and preventive actions to reduce recurrence.
- Mentor junior team members, potentially including oversight and/or management of up to 3 CRAs
- Review and maintain Trial Master File (TMF) documentation for audit readiness; ensure alignment with Good Documentation Practices and regulatory expectations (FDA, ISO, OUS).
- 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 site management experience, including prior field monitoring experience.
- Strong background in medical devices; 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 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, Veidoc); working knowledge of CTMS and eTMF systems.
- Thorough knowledge of GCP, FDA, ISO, and other relevant regulatory frameworks.
- People leadership experience a plus.
- Clinical research certification (ACRP or SOCRA, CRA/Coordinator certification) preferred.
- Ability to travel extensively (30-50% during activation and early enrollment; ~30% otherwise) across the US and Canada.
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, performance-based bonuses, and stock options.
- Career development opportunities and a chance to be part of a growing company that values its employees.
Health and Wellness Offerings:
- Medical, Dental, and Vision Offerings
- Healthcare & Flexible Spending Account (HSA / FSA)
- 401k + Company Match
- Life, AD&D, Short Term and Long-Term Disability Insurance
- Bonus Plan Eligibility
- Employee Equity Program
- Paid Holidays & Vacation
- Employee Assistance Program
- Inclusive Team Environment
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, multiculturism 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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Job Tags
Temporary work, Local area, Remote work, Flexible hours,