CHEManager International · 2 days 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 will play a key role in the execution of the global pivotal trial, ensuring quality and compliance through oversight and direct monitoring of clinical sites.
Newspapers
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; 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
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) across the US and Canada
Preferred
Experience in a Cardiac Cath Lab setting highly preferred
People leadership experience a plus
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
CHEManager International
Wiley’s leading media brand providing first-hand information on the global chemical, life science and process industries
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase