Director of Study Operations
On-siteMiami, Florida, United States
Job Summary
Provide effective, proactive leadership to Clinical Research Coordinator, Data Coordination, and Medical Records teams to ensure quality care delivery and meet site-specific key performance indicators. Ensure timely data management and communication with monitors and auditors while maintaining full GCP compliance and SOP adherence. Support study acquisition and activation by facilitating protocol reviews and overseeing accurate data collection in Veeva and other systems. Review incoming protocols for feasibility and collaborate with regulatory, quality, and site development departments to ensure successful care delivery. Use continuous process improvement techniques to proactively identify and address areas for improvement across the organization. Collaborate with the Director, Nursing to lead site operations and act as a change agent for strategic project efforts at the local and regional levels.
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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