Merissa Brophy
Sr. Clinical Research Associate I at Parexel FSP
- Role
- Clinical Research Associate at Parexel
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Merissa Brophy
As a dedicated Clinical Research Professional with three years of experience in clinical…
Experience
Clinical Research Associate
Aug 2024 — Present · 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 (e.g, remote where allowed by local regulations and onsite when necessary) in line with the Study Monitoring Plan (SMP), to include but not limited to: • Informed consent review in accordance with the SMP requirements • Reviewing/verifying source and data in accordance with SMP requirements • Verifying Investigational Product (IP) inventory, dispensation/administration, reconciliation, compliance, storage and security • Collaborating with the site staff (Site Manager, investigators, and institutions) and internal team members (Study Order Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP)), 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 deliverables. • Documenting activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP.
Education
Temple University
Bachelor of Science - BS
2019 — 2021
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