Summary

The Senior Clinical Research Coordinator (Sr. CRC) role provides direct management to fast-paced and detailed therapeutic/interventional drug and device clinical research trials at BCM and Texas Children's Hospital, across a variety of disease areas. This position requires the ability to coordinate a large 5 year COVID clinical trial with study activities occurring at multiple locations. The Sr. CRC must have the ability to be proactive and interface with multiple departments across the College and outside of the organization. This position will develop, implement, and coordinate clinical research and logistical procedures for the successful management of clinical trials. The Sr. CRC will perform clinical research duties requiring analysis, sound judgment, critical thinking skills, and a high level of knowledge of study specific protocols. This position will work independently with minimal general guidance.

Job Duties

• Clinically and administratively manages a single study involving rapid scale up and a high volume of patients/participants in a complex clinical trial.
• Adheres to Baylor College of Medicine, Texas Children’s Hospital and Clinical Research SOPs.
• Adheres to FDA Good Clinical Practices outlining the standard for safety, design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies.
• Verifies eligibility of patients for enrollment in studies based on comprehensive inclusion and exclusion criteria outlined in the protocol.
• Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials.
• Discuss study protocols with patients and verifies the informed consent documentation.
• Dispense study medication in a professional and accountable manner following protocol and hospital requirements.
• Ensures that non-serious and serious adverse events are properly documented and reported to internal and external agencies as needed per protocol requirements and federal guidelines.
• Trains lower level clinical research personnel regarding enrollment, recruitment, EMR transactions, and SOPs.
• Oversees and guides lower level clinical research personnel regarding study set up and SOPs.
• Participates in study feasibility by completing a comprehensive review of protocol and study logistics such as staffing resources, patient population, and clinical resources needed to correctly conduct study.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Clinical trial drug and/or device experience
• ACRP Certified Clinical Research Coordinator or SOCRA Certified Clinical Research Professional certification
• EPIC experience