Senior Clinical Research Associate – Medical Devices
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Job Description
Senior Clinical Research Associate overseeing pivotal trials for cardiac device innovation. Ensuring compliance and quality standards while collaborating with clinical teams nationally.
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
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)
- Ability to work without visa sponsorship of any kind
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
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