SUMMARY

The Lead, Clinical Research is responsible for managing the clinical and administrative operations of research studies within the Center for Research Advancement (CRA), Department of Molecular and Human Genetics. This role serves as the operational lead for study start-up and coordination of Molecular and Human Genetics research programs at Texas Children’s Hospital (TCH), ensuring alignment with institutional goals and regulatory standards.

MINIMUM QUALIFICATIONS

• Bachelor’s degree.
• Six years of relevant experience.

PREFERRED QUALIFICATIONS

• Advanced 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.

• Develop and lead operational workflows for complex clinical trials, including multi-departmental and multi-site studies.
• Collaborate with the CRA Clinical Trial Finance team to obtain institutional quotes and support budget negotiations with sponsors.
• Partner with CRA leadership and BCM-TCH faculty to evaluate and initiate new clinical and pre-clinical studies.
• Draft, review, and maintain standard operating procedures (SOPs) for CRA operations.
• Oversee the execution of multiple clinical trials, ensuring adherence to timelines, protocols, and quality standards.
• Lead the completion of key deliverables and critical milestones for complex studies.
• Collaborate with the CRA Regulatory team to draft informed consent forms and prepare regulatory submissions.
• Support the protocol approval process and manage study initiation, monitoring, and close-out activities.
• Mentor and delegate tasks to junior research staff, providing training and oversight.
• Work with CRA leadership to assign clinical trials and daily responsibilities across the team.
• Identify potential operational challenges, propose solutions, and escalate issues to leadership, sponsors, and investigators as needed.
• Interview, screen, and recruit patients for study enrollment.
• Educate participants on study procedures and informed consent.
• Collect and manage patient data through interviews, questionnaires, and chart reviews; enter data into case report forms and databases.
• Ensure compliance with FDA Good Clinical Practice (GCP) guidelines and institutional SOPs from Baylor College of Medicine and Texas Children’s Hospital.
• Serve as the primary CRA operations lead for Molecular and Human Genetics clinical trials at TCH, including rare disease, gene therapy, and first-in-human studies.
• Coordinate with genetic counselors, laboratory scientists, and clinical faculty to ensure protocol feasibility and alignment with departmental research priorities.
• Support the integration of clinical genomics and precision medicine initiatives into research workflows.
• Facilitate collaboration between CRA, the Department of Molecular and Human Genetics, and external sponsors for the development of novel therapeutic studies.
• Ensure compliance with specialized regulatory requirements for genetic and genomic research, including IRB, FDA, and NIH guidelines.
• Assist in the development of departmental research infrastructure, including databases, biorepositories, and patient registries.
• Performs other job-related duties as assigned.