Anteris Technologies · 2 hours ago
Senior Clinical Research Associate
Minnesota, United States
Full-time
Hybrid
Senior Level
5+ years expAnteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care. The Sr. Clinical Research Associate (CRA) will play a key role in the execution of global pivotal trials, ensuring quality and compliance while overseeing vendor activities, conducting site visits, and mentoring junior team members.
BiotechnologyHealth CareMedical
Hiring Manager
Erica Almgren Steffenson
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
Qualification
Required
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
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
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
Ability to travel extensively (30-50% during activation and early enrollment; :30% otherwise)
Preferred
Class III cardiovascular device experience highly preferred
Experience in a Cardiac Cath Lab setting highly preferred
Clinical research certification (ACRP or SOCRA, CRA/Coordinator certification) preferred
Benefits
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
Company
Anteris Technologies
Anteris Technologies is a structural heart company focused on developing innovative & durable health solutions.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$34.29MKey Investors
Partners for Growth
2023-02-09Post Ipo Equity· $24.29M
2017-10-01Post Ipo Debt· $10M
2004-03-24IPO
Leadership Team
Wayne Paterson
CEO and Managing Director
David St. Denis
Chief Operating Officer
Recent News
Anteris Technologies Pty Ltd
2025-11-18
Anteris Technologies Pty Ltd
2025-11-13
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2025-11-03
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