Director of Study Operations

Job Title: Director of Study Operations

Work Location: Allegheny County, Pennsylvania

Summary:

Seeking a Director of Study Operations to lead research operations in oncology clinical research. This role oversees Clinical Research Coordinator, Data Coordinator, and Medical Records teams, ensuring high-quality patient care and compliance with regulatory standards. The position involves collaboration with nursing and shared services, process improvement, and oversight of department processes, training, recruitment, and supervision.

Responsibilities:

• Lead and provide direction to Clinical Research Coordinator, Data Coordination, and Medical Records teams to ensure quality care and achievement of key performance indicators.
• Oversee staff training, competency assessments, and management for all team members within areas of responsibility.
• Ensure compliance with GCP, regulatory standards, and SOPs, including data management, documentation, and audit readiness.
• Support study acquisition and activation, facilitate protocol review meetings, and oversee accurate data collection and documentation in required systems.
• Implement efficient processes and systems to support patient care workflows and compliant clinical research protocol execution.
• Utilize continuous process improvement techniques to identify and address operational improvements for patients, staff, and the organization.
• Review incoming protocols for operational feasibility, focusing on research coordinator team capabilities.
• Foster effective communication and collaboration with regulatory, quality, site development, pharmacy, and finance departments to ensure compliance and successful care delivery.

Qualifications:

• Bachelor’s degree required.
• 5 years of leadership experience in an oncology clinical research setting.
• CITI GCP training.
• Knowledge of GCP, GDPR, and federal clinical research regulations in the US.
• Familiarity with Microsoft Office applications and clinical documentation systems.
• Master's degree in health administration, nursing, or related field preferred.
• BLS/ACLS certification preferred.
• Ability to work in a fast-paced, dynamic healthcare environment with demanding deadlines.
• Experience working closely with physicians and ancillary personnel in oncology/hematology patient care.
• Willingness to travel intermittently (less than quarterly) to support new site activation.

Published Category:

Clinical Operations & Development