Principal Clinical Research Associate

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Mar 2024 - Mar 2026 Principal Clinical Research Associate @ EBR Systems, Inc.

Contributed to preparation of CSA and budget agreements for study start-up investigator sites; contributed to preparation of informed consent documents; continued responsibilities from Sr. CRA role including monitoring, compliance, and study execution support.

Mar 2021 - Mar 2024 Sr. Clinical Research Associate @ EBR Systems, Inc.

Performed interim monitoring visits including site initiation and site closeout; maintained and audited study master files in Veeva Vault eTMF; trained and mentored other CRAs; reviewed and approved monitoring visit reports; contributed to clinical study reports and regulatory updates; supported audit readiness; identified and documented adverse events; supported CRF development.

May 2018 - Dec 2020 Clinical Research Associate @ Stryker

Performed interim monitoring visits including site initiation and closeout; maintained and audited study master files; trained and mentored CRAs; processed invoices and prepared monthly Accounts Payable accrual reports; completed annual IRB submissions, continuing review renewals, and closeout reports.

Jul 2017 - May 2018 Clinical Research Associate @ Kelly Services

Performed site monitoring and auditing activities for post-market studies; maintained and audited study master files; maintained internal study files to ensure compliance with applicable regulations.

May 2016 - Jun 2017 Clinical Research Associate @ Health Policy Associates, Inc.

Performed site monitoring and auditing activities for IDE, IND, and post-market studies; assisted with editing clinical study reports.

Jan 2010 - Apr 2016 Clinical Research Associate @ Merz North America, Inc.

Monitored investigational sites to ensure data integrity and protocol compliance; maintained and audited study master files; performed data management for marketing clinical studies; coordinated with data management and clinical project management teams; maintained internal study files to ensure regulatory compliance; trained and mentored CRAs.