Senior Clinical Research Associate – Medical Devices

Anteris Technologies

Senior Clinical Research Associate overseeing pivotal trials for cardiac device innovation. Ensuring compliance and quality standards while collaborating with clinical teams nationally.

Posted 4/29/2026full-timeRemote • Minnesota • 🇺🇸 United StatesSenior💰 $130,000 - $145,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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)
Ability to work without visa sponsorship of any kind

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

site managementfield monitoringclinical data verificationdiscrepancy resolutionregulatory compliancetrial master file managementdata cleaningproblem-solvingcritical thinkingorganizational skills

Soft Skills

communication skillsmentoringattention to detailleadership

Certifications

ACRP certificationSOCRA certificationCRA certification