Senior Clinical Research Associate - Medical Devices

Anteris Tech

13d•Remote

About The Position

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.

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.
Ability to work without visa sponsorship of any kind

Nice To Haves

Class III cardiovascular device experience
Experience in a Cardiac Cath Lab setting
FDA BIMO experience
People leadership experience
Clinical research certification (ACRP or SOCRA, CRA/Coordinator certification)

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.

Benefits

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.
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