Panthera BiopartnersSenior Clinical Research Associate
Jan. 2024 - Jun. 2024London, England, United KingdomOn-site CRA responsible for site management of all active and historical studies. - Provided oversight of the Site Compliance Specialist team, supporting daily tasks such as ISF and source data maintenance, EDC query resolution, and study vendor management.
-Led the collation and closure of issues from past CRA visits and monitoring letters.
- Collaborated cross-functionally with the clinical, patient coordinator, and lab teams to ensure high-quality study conduct aligned with ICH-GCP and Sponsor/CRO expectations.
- Contributed to all study phases including start-up, maintenance, close-out, and archiving.
- Managed communications with internal and external stakeholders including CRAs, Project Management, Quality Assurance, Medical Director, and the CEO.
- Oversaw quality systems by tracking and resolving Quality Issues (QIs), preparing for audits, and mentoring and developing site staff.
- Supported PI oversight and Sponsor/CRO visits.
- Regularly developed and presented site performance metrics and study updates to the Senior Leadership Team (SLT), addressing progress, ongoing issues, and timelines for resolution.