Senior Clinical Research Associate
BeOne Medicines
Full-time
Remote friendly (United States)
United States
$105,800 - $140,800 USD yearly
Clinical Research and Development
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Role Summary
Senior Clinical Research Associate (SCRA) responsible for monitoring assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and SOPs. Collaborates with Clinical Study Teams, mentors CRAs, and seeks opportunities to improve site management and study delivery across the Americas region.
Responsibilities
- Perform and coordinate clinical monitoring activities to assess safety and efficacy of investigational products or medical devices per GCPs and SOPs
- Conduct site visits to verify protocol and regulatory compliance and prepare documentation
- Develop collaborative relationships with investigative sites and study vendors
- Track enrollment and study-specific status reports to ensure milestones are met
- Mentor/trainer for less experienced CRAs; assist with monitoring visit report reviews and managerial tasks
- Provide study-specific training and develop monitoring tools for efficient data review
- Perform SAE reconciliation and resolve discrepancies with sites and CRAs
- Review outstanding data reports to ensure data collection aligns with contractual guidelines
- Work with CTOMs and CST to manage site trends via dashboards and risk assessments
- Collaborate with CST and sites to ensure timely milestones (startup, recruitment, analyses, closeout)
- Support audits/inspections preparation and follow-up; address quality issues and findings
- Assist with other clinical responsibilities to support junior staff
Qualifications
- Understand clinical trial processes with knowledge of ICH guidelines
- Minimum 4–6 years of relevant Clinical Operations experience
- Minimum 3–4 years of CRA monitoring experience in pharma or CRO
- Excellent communication, interpersonal, and organizational skills
- Ability to prioritize and multi-task
Skills
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
- Familiarity with industry CTMS and data management systems
Education
- BS/BA in a relevant scientific discipline; 4–6 years of Clinical Operations experience and 3–4 years of monitoring experience; global oncology trials preferred
Additional Requirements
- Travel up to 40–60% time