Senior Clinical Research Associate

November 23

❄️ Minnesota – Remote

Although this job is listed in Minnesota, this company may be open to hiring remote in other states.

💵 $130k - $145k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Anteris Technologies

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Anteris Technologies is a structural heart company focused on developing innovative solutions to the biggest challenges facing aortic stenosis patients and their physicians.

51 - 200 employees

💰 Post-IPO Equity on 2023-02

📋 Description

• 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

• 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.

🏖️ 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