Principal Clinical Research Associate
About Me
I am a Principal Clinical Research Associate with extensive experience supporting medical device and pharmaceutical clinical trials. My background centers on site monitoring, GCP and SOP compliance, data integrity, patient safety, and audit readiness.
I have worked across the full clinical study lifecycle, including site initiation, interim monitoring, and closeout. I have also supported study start-up activities such as CSA and budget agreements, informed consent preparation, and IRB submissions.
A major part of my work has involved maintaining and auditing study master files and eTMF systems, especially in Veeva Vault. I have also reviewed monitoring reports, supported inspection preparation, and helped ensure studies remained compliant and inspection-ready.
I am experienced in identifying, documenting, and following up on adverse events, as well as supporting regulatory reporting and clinical study documentation. I have contributed to clinical study reports, ClinicalTrials.gov updates, and other external submissions.
Throughout my career, I have collaborated closely with internal clinical teams, CROs, sites, IRBs, and regulatory stakeholders. I am known for being detail-oriented, reliable, flexible, and effective in cross-functional communication.
I also enjoy mentoring and training other CRAs. I have consistently supported less experienced team members by reviewing monitoring reports, sharing knowledge, and helping strengthen clinical operations execution.
Skills
CommunicationAnalytical SkillsAdobeRegulatory Reporting
Education
No education data available.
Experience
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.
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.
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.
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.
Performed site monitoring and auditing activities for IDE, IND, and post-market studies; assisted with editing clinical study reports.
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.