Director of Study Operations

START Center for Cancer Research • Atlanta, GA

1d • Onsite

About The Position

The Director of Study Operations leads research operations and ensures study conduct follows START standards and applicable regulatory requirements while maintaining high-quality patient care. The role provides direction and oversight to Clinical Research Coordinator, Data Coordinator, and Medical Records teams with a high degree of autonomy. It works closely with the Director of Nursing and Shared Services teams to support clinic operations, study acquisition and activation, and quality assurance activities. The Director also oversees department processes, training, recruitment, retention, and supervision within areas of responsibility.

The position is based in Atlanta, Georgia, and follows a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule. It operates in a fast-paced, changing healthcare environment and involves intermittent travel, less than quarterly, to support new site activation.

Requirements

• Bachelor’s degree.
• Five years of leadership experience in an oncology clinical research setting.
• CITI GCP training.
• Knowledge of GCP, GDPR, and U.S. federal clinical research regulations.
• Familiarity with Microsoft Office applications and clinical documentation systems.

Nice To Haves

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

Responsibilities

• Lead the Clinical Research Coordinator, Data Coordination, and Medical Records teams to support quality care and meet site-specific key performance indicators.
• Provide effective training and ensure staff and management demonstrate competency in their respective roles.
• Ensure timely data management and communication with monitors and auditors, compliance with GCP, and training documentation for data management staff.
• Uphold SOPs, including review and revision as described in the Global QMS program.
• Support study acquisition and activation with the global shared services team, including facilitating protocol review meetings and overseeing accurate data collection and documentation in Veeva and other required systems.
• Ensure departments use efficient processes and systems to support patient-care workflows and compliant care delivery under clinical research protocols.
• Use continuous process improvement techniques to identify and address areas for improvement for patients, team members, and the organization.
• Review incoming protocols for feasibility with respect to clinical research operations, particularly research coordinator teams.
• Coordinate with regulatory, quality, site development, pharmacy, and finance departments to support care delivery and compliance with federal, GCP, and regulatory agency requirements.
• Support effective use and implementation of CTMS, EHR, and other software for appropriate documentation and data capture.
• Collaborate with department leaders to identify and address process improvements.
• Collaborate with the Director of Nursing to lead site operations and support strategic projects locally and regionally.
• Direct department processes, training, employee recruitment, retention, and supervision for areas of responsibility.

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.
• Medical, dental, and vision coverage, with optional insurance options.
• Company-paid life and disability insurance.
• Employee Assistance Program providing confidential, no-cost support for employees and families from day one.
• Flexible FSA and HSA plans.
• A supportive environment that values balance, wellbeing, and flexibility.
• Collaborative workplace emphasizing continuous learning, professional growth, inclusion, and innovation.

What This Job Offers

• Job Type: Full-time
• Career Level: Director