Senior Clinical Research Associate – EU, Medical Devices
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Job Description
Senior Clinical Research Associate managing CRO oversight and clinical monitoring for pivotal trials. Focused on compliance, quality, and patient safety in innovative cardiac care at Anteris Technologies.
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 (co)-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 (Good Clinical Practice), GDPR, local and global regulations.
- Identify, investigate, and resolve discrepancies in study documentation; implement corrective and preventive actions to reduce recurrence.
- Review and maintain Trial Master File (TMF) documentation for audit readiness; ensure alignment with Good Documentation Practices and regulatory expectations (e.g., FDA, ISO14155, EU-MDR).
- 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 clinical site management experience, including prior field monitoring experience.
- Strong background in medical devices required; 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 or 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, Viedoc); working knowledge of CTMS and eTMF systems.
- Thorough knowledge of GCP, FDA, ISO14155, and other relevant regulatory frameworks.
- Clinical research certification (ACRP or SOCRA, CRA/Coordinator certification) preferred.
- Ability to travel up to 50% during activation and early enrollment; ~30% otherwise across Europe.
- Fluent in spoken and written English required.
- Preference given to qualified candidates with fluency in French and German.
Benefits:
- 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 and performance-based bonus.
- Career development opportunities and a chance to be part of a growing company that values its employees.
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