Summary

Responsible for overseeing and directing the day-to-day clinical research operations of the Molecular and Human Genetics research coordination team within the Center for Research Advancement (CRA), Department of Pediatrics. This role provides leadership and supervision to CRA Genetics research coordinators, ensuring the efficient planning, recruitment, and execution of assigned clinical studies.

Oversees all aspects of study coordination, regulatory compliance, data collection, and documentation. Ensures adherence to study protocols, timelines, and quality standards while fostering collaboration across multidisciplinary teams.

This position directly impacts patient safety by providing oversight of clinical research studies involving the administration of therapeutic agents. It also affects research funding for the department by assisting Principal Investigators in completing funded clinical research studies. The role plays a key part in improving the quality and outcomes of clinical research within the department.

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. Promotes excellence in research operations through mentorship, study oversight, regulatory compliance, and process optimization.

Job Duties

• Supervise the clinical trial research support team within the Center for Research Advancement.
• Provide training and guidance on regulatory requirements and best practices.
• Lead recruitment, hiring, onboarding, and training of clinical research staff.
• Assign clinical trial responsibilities to team members and provide performance feedback to leadership.
• Oversee staff development, administrative actions, and performance evaluations.
• Manage complex clinical research studies, ensuring compliance with reporting and regulatory requirements.
• Ensure subject safety and adherence to study protocols.
• Develop essential study tools such as manuals of operations, source documents, and study orders to support accurate data collection and regulatory compliance.
• Ensure adherence to Good Clinical Practice (GCP) standards and institutional/federal regulations.
• Design and deliver training on sample processing, storage, and shipment procedures.
• Mentor junior staff in study setup and maintenance across various study types (PI-initiated, industry-sponsored, and multi-site consortium studies).
• Assist principal investigators with the development and maintenance of electronic databases.
• Performs other job-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Four or more years of experience in clinical trials.
• Experience in managing clinical research staff and study assignments.
• Advanced degree in a scientific or health-related field.
• Certification as a Clinical Research Professional (CRP) or Clinical Research Coordinator (CRC) from SoCRA or ACRP.
• Strong organizational and communication skills.
• Ability to communicate effectively with hospital and research leadership.
• Experience in managing a Clinical Research Support Team.