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.

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.

Senior Clinical Research Associate

Key skills