Director of Study Operations
On-sitePittsburgh, Pennsylvania, United States
Job Summary
Lead Clinical Research Coordinator, Data Coordination, and Medical Records teams to ensure quality care delivery and meet site-specific key performance indicators. Provide effective training, demonstrate staff competency, and ensure timely data management with full GCP compliance and audit readiness. Support study acquisition and activation by facilitating protocol reviews and overseeing accurate documentation in Veeva and other systems. Review incoming protocols for feasibility, optimize department processes, and collaborate with regulatory, quality, and shared services teams to ensure successful care delivery. Utilize continuous process improvement techniques to address areas for improvement across the organization. Work Monday-Friday 8:00am-5:00pm with approximately 80% of time spent sitting.
Required Qualifications
- Bachelor's degree
- 5 years of leadership experience in an oncology clinical research setting
- CITI GCP training
- Knowledge of GCP, GDPR and federal clinical research regulations required in US
- Must be familiar with Microsoft Office applications and clinical documentation systems
- Approximately 80% of time is spent sitting
- Intermittent travel, less than quarterly, to support new site activation
Desired Qualifications
- Master's degree in health administration, nursing or other related field
- BLS/ACLS
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