Overview In this role you will lead clinical research operations at Winship, ensuring rigorous oversight of trial teams and regulatory compliance. You will partner with investigators and cross-functional partners to accelerate timely trial delivery and data integrity. You will shape training, SOPs, and sponsor engagement to support high-quality cancer trials. This leadership position offers impact by strengthening clinical research programs and patient education within a world-class cancer center.
Responsibilities- Provide direct supervision of Clinical Research Nurses, Coordinators, Assistant Managers, and Operations Managers
- Hire, train and evaluate staff; oversee staff effort reporting for financial management
- Develop and implement SOPs for adverse events reporting and regulatory compliance
- Monitor responses to sponsor queries and ensure timely data updates in CRFs
- Incorporate ONCORE into daily operations and ensure timely data in Oncore
- Educate Winship community and Emory personnel on all aspects of clinical trials
- Develop Winship-specific learning standards for coordinators and physician-investigators
- Collaborate on patient education resources and protocol materials for staff orientation
- Maintain regulatory compliance with FDA, GCP, ICH; support protocol governance and safety
- Foster sponsor relationships and maintain investigator engagement through regular touchpoints
Key requirements- Master's degree in a health-related discipline or MBA with five years of progressively responsible clinical trials or related experience including supervisory experience
- Experience in staff development, process improvement, and regulatory compliance
- Strong ability to manage multiple stakeholders and sponsor relationships
- PREFERRED: SOCRA/ACRP or related research certification
- leadership
- communication
- proactive issue resolution
- FDA, GCP, ICH regulatory knowledge
- Clinical trials operations
- ONCORE data management and integration
