Director, Study Operations

The START Center for Cancer Research (“START”) is the world’s largest early phasesite network, fully dedicated tooncologyclinical research.

Throughout our history, START has provided hope to cancer patients inglobalcommunity practices by offering "Hope Through Access"tocutting edge trials throughout the United Statesand Europe.

We areseekinga

Director of Study Operations.

This role will lead research operations, ensuring all aspects of study conduct are performed according to START standards, regulatory standards, and with 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.

The Director, Study Operations collaborates closely with the Director, Nursing and Shared Services teams to support overall clinic operations, Study Acquisition / Activation and Quality Assurance activities. In addition, this role will provide direction for: department processes, training, employee recruitment, retention, and supervision for their areas of responsibility.

The annual base salary for this role is $ 145,000-$ However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience.

Work Schedule:

Monday-Friday 8:00am-5:00pm

Location:

Manhattan, New York

• Provide effective, proactive leadership to Clinical Research Coordinator team, Data Coordination team and Medical Records 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 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 the patients, team members and the organization as a whole.
• 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.

• 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 US.
• Must be familiar with Microsoft Office applications and clinical documentation systems.

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

• 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…