Clinical Trial Associate II
On-siteRaleigh, North Carolina, United States
Job Summary
Conduct daily clinical study activities including regulatory inspection readiness, protocol oversight, and site initiation support for complex, accelerated, and business essential studies. Approve study documentation, manage risk-based monitoring, and prepare materials for regulatory inspections while collaborating with the Clinical Operations Manager, study teams, and CROs. Execute departmental and developmental tasks under CTA Manager oversight, coordinate with internal departments and vendors, and escalate clinical trial insurance issues. Requires 2+ years in pharmaceutical or clinical research roles, experience with Phase 2/3 studies, and 5-10% domestic and international travel.
Required Qualifications
- Associate or Bachelor's degree in Life Sciences or Healthcare
- 2 or more years' experience in pharmaceutical industry, clinical research organization, or related role
- Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis
Desired Qualifications
- Experience in Phase 2 and 3 studies and global/international studies is advantageous
- Experience working across multiple therapeutic areas is advantageous
- Knowledge in global regulatory and compliance requirements for clinical research
- Excellence in task management and collaboration
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