Summary

The Senior Clinical Research Coordinator is a key member in the Center for Research Advancement in the Department of Pediatrics at Texas Children's Hospital.  Responsible for independently managing the daily operations of complex clinical research studies. This role leads patient enrollment, screening, and consent processes, while ensuring compliance with regulatory standards and study protocols. The coordinator performs and oversees clinical procedures, manages data collection and reporting, and maintains accurate regulatory documentation.

This position will lead a complex clinical trial.  Applicants should have advance knowledge of clinical research and are able to operate in a highly independent manner with minimal oversight.  Applicants should be able to comfortable communication with internal and external stakeholders (Investigators, Faculty, Sponsors).

Senior Reserch Coordinator must have the ability to be proactive and effectively communicate with multiple departments across the College and outside of the organization. Must be able to manages a highly demanding complex clinical study involving rapid scale up and a high volume of patients/participants.

Flexibility to work occasional evenings or weekends is required.

Job Duties

• Independently manage the day-to-day operations of complex clinical research studies across multiple therapeutic areas.
• Lead patient enrollment activities, including recruitment, screening, interviewing, and obtaining informed consent.
• Educate study participants and their families on study protocols, procedures, and expectations.
• Perform and document clinical procedures such as venipuncture, ECGs/EKGs, vital signs, and other protocol-specific assessments.
• Collect and record clinical data related to study procedures, including catheterizations, cardiac measurements, and diagnostic tests.
• Ensure timely and accurate data entry into electronic case report forms (eCRFs) and Clinical Trial Management Systems (CTMS).
• Schedule and coordinate study visits, laboratory tests, imaging, and other protocol-required procedures.
• Collect, process, store, and ship biological specimens in accordance with study protocols and IATA guidelines.
• Maintain and update regulatory documents, source documentation, and study records in compliance with FDA, IRB, and institutional requirements.
• Communicate regularly with study participants, families, investigators, and sponsors to ensure smooth study conduct.
• Interact with sponsors, coordinating centers, and regulatory agencies to facilitate study activities and maintain up-to-date documentation.
• Order, track, and manage study supplies, equipment, and investigational products.
• Review and interpret study protocols, abstracts, and informed consent forms for relevant operational and regulatory information.
• Communicates and follow up on serious adverse event (SAE) reports and other safety documentation.
• Collaborate with physicians, mid-level providers, research nurses, and data managers to ensure accurate and timely documentation of patient care.
• Participate in study feasibility assessments, including evaluation of staffing, patient population, and resource needs.
• Provide cross-coverage and support across the research portfolio as needed.
• Develops SOP's and contributes to the continuous improvement of the clinical research process.
• Assist the regualtory team to ensure compliance with FDA, IRB, and institutional policies.
• Performs other job duties as assigned.

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

• Bachelor's degree in a Basic Science, Healthcare, Public Health, or similar field.  
• Five years of relevant experience in clinical research or healthcare. 
• ACRP Certified Clinical Research Coordinator or SOCRA Certified Clinical Research Professional certification.
• EPIC experience.
• Therapeutic clinical research study experience.
• Knowledge of FDA Good Clinical Practices.
• Knowledge and familarity with Neurology clinical research studies.