Study Director Jobs

About The Position

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 delivery and meet site-specific key performance indicators.
• Train staff and the management team and demonstrate competency for their respective roles.
• Ensure timely data management and communication with monitors and auditors, compliance with GCP, and complete training documentation for data management staff.
• Uphold SOPs, including reviewing and revising them as required by 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 that support patient-care workflows and compliant care delivery under clinical research protocols.
• Use continuous process improvement techniques to identify and address opportunities 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 implementation and use of CTMS, EHR, and other software for appropriate documentation and data capture in the departments of responsibility.
• Collaborate with department leaders to identify and address process improvements.
• Collaborate with the Director of Nursing to lead site operations and advance 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 their families from day one.
• Flexible FSA and HSA plans.
• A supportive environment that values balance, well-being, and flexibility.
• Collaborative workplace emphasizing continuous learning, professional growth, shared ideas, inclusivity, and innovation.