Summary

Manages clinical research study operations in the Department of Pediatrics for the Research Resources Office and the Pediatrics GI/Pulmonary Divisions. Manages the day-to-day operations for multiple studies. Leads the planning and scheduling activities for assigned clinical study assignments. Oversees study data collection and documentation activities and assignments. Manages Research Resources Office clinical research staff.

Takes a lead role in the department's clinical research activities and supports the mission of research at Baylor College of Medicine. Directly impacts patient safety by offering oversight to clinical research studies where therapeutic agents are being administered. Impacts research funding for the department by assisting Principal Investigators with completing funded clinical research studies. Improves the outcomes of clinical research within our department.

Job Duties

• Manages complex clinical research studies in the Research Resources Office and the Pediatrics GI/Pulmonary Divisions.
• Manages clinical research employees, their activities and workload.
• Leads the planning and scheduling activities for direct reports and provides feedback to leadership on study assignments.
• Oversees daily work of direct reports and provides ongoing feedback and coaching on RRO SOPs and clinical research conduct.
• Manages a team of research coordinators and data managers. Responsible for their development, administrative actions, and performance reviews.
• Develops and presents training and education on procedures related to sample processing, storage, and shipment.
• Manages the day-to-day operations for multiple studies.
• Under the study directives, manages overall study conduct by ensuring subject safety is maintained, protocol activities are appropriately carried out, and regulations/GCP practices are followed.
• Ensures good clinical practice standards, institutional and federal compliance regulations are adhered to.
• Oversees reporting and compliance activities.
• Performs other job-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Bachelor’s degree in a scientific or health-related field. Advanced degree is a plus.
• Minimum of four years of clinical trial experience.
• Experience managing study assignments and/or clinical research staff.
• Certification as either a Clinical Research Professional (CRP) or Clinical Research Coordinator (CRC).
• Certification should be from the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP).
• Certification is strongly preferred for this role.