Director, Study Operations

About the role

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. START has provided hope to cancer patients in global community practices by offering “Hope Through Access” to cutting edge trials throughout the United States and Europe. We are seeking a Director of Study Operations to lead research operations, ensuring all aspects of study conduct are performed according to START standards, regulatory standards, and with the highest quality patient care. This role provides direction and oversight to the Clinical Research Coordinator, Data Coordinator and Medical Records teams with a high degree of autonomy, and collaborates closely with the Director, Nursing and Shared Services teams to support overall clinic operations, Study Acquisition / Activation and Quality Assurance activities.

Responsibilities

• Provide effective, proactive leadership to Clinical Research Coordinator, Data Coordination and Medical Records teams to ensure quality care delivery and ability to meet site-specific key performance indicators.
• 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, full compliance with GCP, and training documentation for all data management staff.
• Uphold all SOPs, including their review and revision as described in the Global QMS program.
• Support study acquisition and activation functions in collaboration with the global shared services team to meet START goals for speedy study start-up and network-wide study acquisition functions, including facilitating protocol review meetings and overseeing accurate data collection and documentation in Veeva and any other required systems.
• Ensure departments are using efficient, effective processes and systems to support patient care workflows and compliant care delivery in the context of clinical research protocols.
• Use continuous process improvement techniques to proactively identify and address areas of improvement for the good of patients, team members and the organization.
• Review all incoming protocols for feasibility with respect to clinical research operations, specifically research coordinator teams.
• Ensure effective inter-departmental interaction and communication with other support departments including regulatory, quality, site development, pharmacy and finance to ensure successful care delivery and compliance with all federal, GCP and regulatory agency requirements.
• Support effective use and implementation of CTMS system, EHR system, and other necessary software to ensure appropriate and accurate documentation and data capture in the departments of responsibility.
• Collaborate with other department leaders to proactively identify and address areas for process improvement.
• Collaborate with Director, Nursing to lead site operations and act as a change agent for strategic project efforts both at the local level and regionally.

Requirements

• 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 the US
• Familiarity with Microsoft Office applications and clinical documentation systems

Preferred qualifications

• Master’s degree in health administration, nursing or other related field
• BLS/ACLS

Physical and travel requirements

• Approximately 80% of time is spent sitting
• Very fast-paced and ever-changing healthcare environment
• Demanding deadlines and time frames
• Constant demand for updating knowledge
• Works closely with physicians and ancillary personnel in caring for and treating oncology/hematology patients
• Intermittent travel, less than quarterly, to support new site activation

Benefits

• 401(k) retirement savings plan with employer match
• Eligibility for an annual performance bonus, based on role and company results
• Generous paid time off and paid holidays
• Comprehensive medical, dental, and vision coverage and optional insurance options
• Company-paid life and disability insurance
• Employee Assistance Program (EAP) providing confidential, no-cost support from day one
• Flexible FSA and HSA plans