Summary

The Pulmonary, Critical Care, and Sleep Medicine section of the Department of Medicine is seeking a Clinical Research Lead to serve as the Team Lead overseeing the Baylor Advanced Pulmonary, Transplant, and Critical Care Clinical Trials Unit (CTU). This role combines responsibilities for both clinical operations leadership and comprehensive financial oversight of clinical trials conducted within the Advanced Pulmonary Transplant and Critical Care CTU. The Lead will ensure operational efficiency and regulatory compliance while managing the full financial life cycle of the trials.

Job Duties

Operational Oversight:

• Identify and evaluate clinical studies for feasibility and strategic alignment.
• Lead study start-up activities: PSV scheduling, sponsor document requests, and feasibility surveys.
• Oversee site training logs, SIVs, and site activation.
• Supervise enrollment, protocol compliance, source documentation, and subject randomization.
• Provide ongoing operational updates and ensure adherence to SOPs.
• Coordinate with CRAs for monitoring visits and resolve action items.
• Ensure oversight of CTMS, EDC compliance, and quality review processes.
• Supervise AE/SAE tracking and reporting workflows.
• Manage IND safety reporting and clinical supply shipping (including dry ice logistics).
• Lead study close-out processes with sponsors and internal units.
• Experience managing federally funded clinical research projects, including NIH, FDA, and DOD grants.

Financial Oversight:

• Review and develop trial budgets in collaboration with the regulatory finance team and sponsors.
• Ensure accurate sponsor billing and monitor ongoing financial health of trials.
• Reconcile Clinicard payments and site-specific expenses.
• Review and process vendor invoices; approve PO creation and renewals.
• Oversee finance reconciliation at the department and unit level.
• Track and validate staff effort allocations and finalize financial reports for studies.
• Manage administrative cost reviews and invoice sponsors for trial-related costs.
• Maintain financial data accuracy in systems (e.g., Epic, CTMS).
• Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Six years of relevant experience.

Preferred Qualifications

• Master’s degree in Health Sciences, Business Administration, or a related field is preferred.
• Six years of experience in clinical research operations, including a minimum of 2 years in a leadership capacity.
• Must have hands-on experience with clinical trial management and financial oversight in a clinical trials environment.
• Proficient in Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) platforms, Epic billing systems, and Microsoft Excel.
• Deep understanding of clinical research financial processes, including budgeting, invoicing, and reconciliation.
• Outstanding organizational and time management capabilities.
• Strong analytical and problem-solving aptitude.
• Excellent interpersonal skills with a proven ability to lead cross-functional teams effectively.

Working Conditions

• Full-time, on-site work.
• May require occasional travel between hospital or clinic sites.
• Flexibility to work extended hours during high-volume periods (e.g., trial launches, monitoring visits).
• May involve exposure to clinical environments or proximity to patient care areas.