Manager, Clinical Research - Pediatrics - Center for Research Advancement Administration

Summary

Responsible for overseeing and directing the day-to-day clinical research operations of the Neurology research team within the Center for Research Advancement (CRA), Department of Pediatrics. Provides leadership and supervision to CRA Neurology research coordinators, ensuring efficient planning, recruitment, and execution of assigned clinical studies. Manages all aspects of study coordination, compliance, data collection, and documentation. Ensures adherence to study protocols, timelines, and quality standards while fostering collaboration across multidisciplinary teams.

Takes a lead role in advancing the department’s clinical research mission at Baylor College of Medicine. Provides strategic oversight and operational leadership for therapeutic clinical research studies, directly impacting patient safety and research quality. Supports Principal Investigators in the successful execution of funded studies, contributing to departmental research funding and improved clinical outcomes. Drives excellence in research operations through mentorship, study oversight, compliance, and process optimization.

Occasional work on the weekends and after hours may be required.

Job Duties

• Manages complex therapeutic research studies across multiple protocols for the Division of Neurology within the Center for Research Advancement (CRA).
• Oversees a team of clinical research professionals, including research coordinators and data managers, ensuring balanced workloads and high-quality performance.
• Leads planning and scheduling of study activities for direct reports; provides strategic input to leadership on resource allocation, recruitment strategies, study assignments. and other key study activities.
• Provides daily oversight, coaching, and performance feedback to staff, ensuring adherence to CRA Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) guidelines.
• Conducts performance evaluations and manages administrative actions for team members, supporting their professional development.
• Designs and delivers training on sample processing, storage, and shipment procedures to ensure protocol compliance and data integrity.
• Directs day-to-day operations for multiple concurrent clinical studies, ensuring timelines, safety, and regulatory requirements are met.
• Ensures subject safety and protocol fidelity by overseeing study conduct in alignment with regulatory and institutional standards.
• Leads the development of study tools, including Manuals of Operations, source documents, and study orders, to support accurate and efficient data collection.
• Mentors junior staff in study startup processes, including multi-center trial coordination.
• Collaborates with Principal Investigators to develop and optimize electronic data capture systems.
• Authors and reviews Standard Operating Procedures (SOPs) to enhance operational efficiency and compliance.
• Oversees reporting and compliance activities, ensuring timely submissions and audit readiness.
• Performs additional duties as assigned to support CRA and departmental goals.

Minimum Qualifications

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

Preferred Qualifications

• Advanced degree (e.g., Master’s in the field of science, Public Health, Clinical Research, or related field).
• Minimum of four (4) years of experience in clinical trials or clinical research.
• Demonstrated experience managing clinical study assignments and/or supervising clinical research staff.
• Strong knowledge of Good Clinical Practice (GCP), FDA regulations, and institutional research policies.
• Certification as a Clinical Research Professional (CRP) or Clinical Research Coordinator (CRC) from: Society of Clinical Research Associates (SoCRA), or Association of Clinical Research Professionals (ACRP).
• Willing to lift 20-30 lbs