Director of Study Operations
Overview
The START Center for Cancer Research seeks a Director of Study Operations to lead research operations ensuring study conduct meets START standards and regulatory requirements while delivering high quality patient care. This role provides autonomy directing Clinical Research Coordinator Data Coordinator and Medical Records teams collaborating with nursing and shared services to support clinic operations study acquisition and quality assurance.
What You'll Do11
- 1Provide proactive leadership to Clinical Research Coordinator team Data Coordination team and Medical Records to ensure quality care delivery and meet site KPIs
- 2Deliver effective training and demonstrate competency of staff and management for respective job roles
- 3Ensure timely data management and communication with monitors and auditors maintaining GCP compliance through thorough documentation
- 4Uphold SOPs within the Global QMS program and facilitate protocol review meetings for accurate data collection in Veeva and other systems
- 5Support study acquisition and activation with shared services meeting network goals for rapid study start up
- 6Promote efficient processes and systems to support patient care workflows and compliant delivery adhering to federal GCP and regulatory agency requirements
- 7Review incoming protocols for feasibility focusing on research coordinator teams
- 8Foster interdepartmental interaction with regulatory quality site development pharmacy and finance to ensure compliance and successful care delivery
- 9Implement CTMS EHR and other software for accurate documentation and data capture
- 10Collaborate with Director Nursing to lead site operations and act as change agent for strategic projects
- 11Identify and address process improvements continuously for patient benefit team member growth and organizational success
Requirements9
- 15+ years building ETL pipelines with Spark and Airflow
- 23-5 seasons leading multidisciplinary teams in clinical research environments
- 3Master's degree in health administration nursing or related field
- 4BLS/ACLS certification
- 5Certified Professional Clinical Manager credential
- 65+ years managing cross functional study operations
- 7Expertise in GCP and clinical trial regulations
- 8Proven track record of driving process improvement initiatives
- 9Strong communication and leadership abilities
Salary Insight
$135 - $145k per year
Location
Required Skills
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