Clinical Research Operations Director

24 hours ago

Nashville, Tennessee, United States Medix™ Full time
Medix™ Job Description

Job Title: Clinical Research Operations Director - Oncology

About the Role:

This senior leadership position is responsible for overseeing the efficient execution of oncology clinical trials, from feasibility to closeout, ensuring compliance with regulatory requirements, timelines, and budgets. The individual will drive strategic initiatives to enhance site performance, improve patient recruitment, and optimize operational processes.

Main Responsibilities:

• Lead the clinical research operations team supporting a large portfolio of sponsored clinical research at multiple locations.
• Ensure regulatory compliance and monitor study coordinator activities, including effective management of research patients per protocol and accurate and timely data collection.
• Develop and implement departmental processes and standard operating procedures (SOPs) to ensure compliance with federal, state, and local regulations and Good Clinical Practice (GCP) guidelines governing the conduct of clinical research in human subjects.
• Drive the development and implementation of new processes and workflows to improve site efficiency, coordination with clients, and overall research quality.
• Provide or partner with other management to conduct employee interviewing, selection, retention, support, and encouragement of staff, ensuring staff has an in-depth knowledge of their jobs and appropriate tasks.
• Collaborate with counterparts at clients on all aspects of research administrative functions, including study activation/start up, centralized regulatory, budgeting/contracting, quality assurance and compliance, training/professional development, study operations, and research finance.
• Facilitate cross-functional collaboration internally and with client departments.
• Maintain and strengthen the brand integrity of the research program by ensuring the quality of data, speed to startup, sponsor satisfaction, and profitability.
• Enhance and grow relationships with key strategic stakeholders.
• Implement and manage department-specific software products as necessary, including CTMS, eRegulatory, etc.
• Create KPIs for all levels of the research team and communicate results/outcomes for continuous learning and improving.
• Launch additional sites/locations as the practice grows throughout Tennessee and bordering states.
• Communicate success stories, metrics, issues, and potential solutions to practice leadership (administrative and physician).
• Develop and implement strategies to enhance patient recruitment and retention across the oncology portfolio.
• Lead the team to maintain a continuous growth and quality mindset.
• Travel to all research site offices as necessary.

Requirements:

• Excellent communication skills.
• Strong analytical, strategic planning, and problem-solving skills.
• Must have thorough understanding of FDA regulations and GCP guidelines.
• Ability to understand complex clinical trials protocols and document requirements.
• Ability to function as an effective team leader.
• Strong understanding of business management, financial, and leadership principles.
• Microsoft Office product knowledge (Word, Excel, PowerPoint, etc.).
• Bachelor's degree in biology, life sciences, or nursing, master's degree in healthcare-related field, MBA preferred.
• Five plus years direct clinical research experience, leadership/management experience.

Estimated Salary: $120,000 - $150,000 per year, based on location and experience.

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