Brianna Barnes
Clinical Research Associate
- Role
- Clinical Research Associate at Parexel
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Brianna Barnes
Clinical Research Associate with a strong background in monitoring clinical trials…
Experience
Clinical Research Associate
Jul 2024 — Present · Durham, NC, US
Ensuring data integrity and quality at the site level by upholding International Council for Harmonization and Good Clinical Practices (ICH GCPs), local requirements, relevant regulations, and all applicable Standard Operating Procedures (SOPs)/processes.Conducting site level monitoring activities in line with the Study Monitoring Plan (SMP), to include but not limited to: Informed consent review in accordance with the SMP requirementsReviewing/verifying source and data in accordance with SMP requirementsVerifying Investigational Product (IP) inventory, dispensation/administration, reconciliation, compliance, storage and securityCollaborating with the site staff and internal team members to assure that the site is in compliance with the protocol and is inspection ready.Ensuring all activities are managed by site personnel who are appropriately delegated and trained.Reviewing data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database deliverablesDocumenting activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP.
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