Summary

Manages clinical research study operations and a clinical research team in the Department of Pediatrics, Research Resources Office and Renal/Endocrine/A&I 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.

Supports Pediatrics, Research Resource Office & Renal/Endocrine/A&I Divisions. Takes a lead role in the department's clinical research activities and supports the mission of research at Baylor College of Medicine. Develops, implements, and oversees Clinical Research Quality Assurance and Quality Control Programs, to ensure compliance with institutional and sponsor guidelines. 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 a Clinical Trial Research Support Team in the Pediatrics, Research Resource Office, and provides training and guidance on regulations and best practices.
• Leads Clinical Trial Research Team recruitment, hiring, onboarding, and training.
• Leads Planning and Scheduling activities and provides feedback to leadership on study assignments.
• Responsible for Research Support Team development, administrative actions, and performance reviews.
• Manages complex clinical research studies, and oversees reporting and compliance activities.
• Manages overall study conduct under study directives, ensuring subject safety is maintained.
• Responsible for the creation of required study tools, such as Manual of Operations, source documents, and study orders to ensure seamless operations and accurate data collection activities are appropriately carried out, and regulations/GCP practices are followed.
• Ensures good clinical practice standards and institutional and federal compliance regulations are followed.
• Develops and presents training and education on procedures related to sample processing, storage, and shipment.
• Mentors junior staff in setting up new studies, including multi-center trials.
• Leads Principal Investigators with electronic database development.

Minimum Qualifications

• Education Required: Bachelor's degree.
• Experience Required: Four years of relevant experience. 
• Certification/Licenses/Registration: None Required.

Preferred Qualifications

• Four years of clinical trial experience.
• Experience managing study assignments and/or clinical research staff.
• Advance Degree in a scientific or health related field.
• Certification as either a Clinical Research Professional (CRP), or Clinical Research Coordinator (CRC) from the Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) is strongly preferred for this role.
• Excellent organizational and communication skills.
• Must be comfortable communicating with hospital and research leadership.
• Comfortable managing a Clinical Research Support Team.