Director of Oncology Study Operations

The START Center for Cancer Research; New York (NY); On-site; USD 145,000 - 155,000; Full time

Benefits offered by this job

401(k) retirement plan

Annual bonus eligibility

Paid time off

Medical, dental, and vision coverage

Life and disability insurance

EAP

Job summary

The START Center for Cancer Research seeks a Director of Study Operations to lead research operations, ensuring study conduct aligns with START standards and regulatory requirements. You will oversee Clinical Research Coordinators, Data Coordinators, and Medical Records with autonomy, collaborating with Nursing and Shared Services to enhance activation and QA activities.

The role emphasizes process improvement, training, and cross-functional leadership while supporting site operations and

Qualifications

• Bachelor's degree required for leadership role in oncology trials.
• Minimum 5 years of leadership experience in oncology clinical research.
• CITI GCP training completed.
• Knowledge of GCP, GDPR and US regulations required.
• Proficient with Microsoft Office and clinical documentation systems.

Responsibilities

• Provide proactive leadership to Clinical Research Coordinator team, Data Coordination team and Medical Records to ensure quality care delivery and ability to meet site specific KPIs.
• Provide effective training and demonstrate competency of staff and management team for respective job roles.
• Ensure timely and effective data management and communication with monitors and auditors, and full compliance with GCP and SOPs.
• Support study acquisition and activation with global shared services to meet START goals for speedy study startup and data collection.
• Ensure departments use efficient processes and systems to support patient care workflows in clinical research.
• Use continuous process improvement techniques to address areas of improvement for patients, teams and the organization.
• Review incoming protocols for feasibility with respect to clinical research operations.

Skills

Leadership

Oncology clinical research

Regulatory compliance

Staff management

Data coordination

CTMS systems

EHR systems

SOPs

Quality assurance

Cross-functional collaboration

Education

Bachelor's degree

Master's degree in health administration or related field

Tools

Veeva

Microsoft Office

Clinical documentation systems

Job description

The START Center for Cancer Research seeks a Director of Study Operations to lead research operations, ensuring study conduct aligns with START standards and regulatory requirements. You will oversee Clinical Research Coordinators, Data Coordinators, and Medical Records with autonomy, collaborating with Nursing and Shared Services to enhance activation and QA activities.

The role emphasizes process improvement, training, and cross-functional leadership while supporting site operations and