Summary

The Research Coordinator III is responsible for coordinating multiple research studies within the Pediatrics Center for Research Advancement – Neurology Research division at Texas Children's Hospital. This role involves managing complex interventional clinical trials sponsored by agencies such as the FDA, NIH, industry partners, and non-profit organizations. The coordinator serves as a key point of contact for sponsors, clinical sites, and internal/external agencies, ensuring smooth communication and effective study execution.

This position works directly with physicians and investigators to review treatment protocols and monitor patient progress. Candidates must possess a solid understanding of FDA Good Clinical Practices and demonstrate the ability to read, analyze, and interpret complex clinical and regulatory information. The role requires independent operation with minimal supervision and the capability to manage either key aspects of large clinical trials or all components of smaller studies. The Research Coordinator III is expected to perform all core functions of clinical research coordination with a high level of competence and professionalism.

This position involves working directly with physicians and investigators to treat and follow up with study patients. Candidates must have a working knowledge of FDA Good Clinical Practices and the ability to read, analyze, and interpret information. 

Applicants must be willing to work in a fast-paced setting, be comfortable working in a team environment, and possess excellent communication skills.

This position supports multiple complex studies in Pediatric Neurology Research and requires study management across multiple sponsors and sites. The role follows standard working hours, but occasional weekend work may be required.

Job Duties

The Research Coordinator III manages multiple research studies, often involving rapid scale-up and high patient/participant volume. These studies include both interventional and non-interventional clinical trials and require coordination across numerous departments to ensure protocol compliance and patient safety. The coordinator participates in study qualification and feasibility assessments. The position also assists in leading and training junior research coordinators and data managers.

Subject Visits – 40%

• Educates research participants about study procedures within the scope of practice.
• Reviews study protocols with participants and verifies informed consent documentation.
• Schedules participants for protocol-specific tests and procedures, including laboratory work.
• Explains study processes and procedures to ensure participant understanding.
• Dispenses investigational medications in accordance with protocol and institutional guidelines; maintains accountability and shipping logs.
• Collects, processes, stores, or ships biological specimens per protocol and lab manuals, following IATA guidelines.

Communication with Sponsors, Subjects, and Principal Investigators – 25%

• Coordinates with sponsors, study sites, and internal/external agencies to facilitate study activities.
• Meets with Principal Investigators and sponsors to lead study qualification and feasibility efforts.
• Manages pending orders for PI review and sign-off; schedules assessments and performs delegated tasks such as ECGs and lab collections.
• Audits and reviews protocol documents, including informed consent forms.
• Generates reports and presents data analyses to stakeholders.
• Implements protocol amendments based on sponsor or site feedback.
• Submits serious adverse event (SAE) reports to IRBs, federal agencies, and sponsors.
• Adheres to FDA Good Clinical Practices and institutional SOPs (Baylor College of Medicine, Texas Children’s Hospital).

Data Collection and Entry – 15%

• Assists Principal Investigators in collecting and recording data from protocol-related procedures (e.g., cardiology, neurobehavioral assessments, imaging).
• Collaborates with physicians, mid-level providers, research nurses, and data managers to document patient care.
• Gathers patient information via interviews, questionnaires, and chart reviews; enters data into databases or case report forms.
• Maintains regulatory documentation and study records to ensure compliance with FDA and other regulatory bodies.

Source Documentation and Development – 10%

• Prepares documentation for initial and continuing IRB approval.
• Develops and implements study materials, including Manuals of Operations, SOPs, and study orders.
• Audits study compliance, generates reports, and presents findings.

Screening and Enrollment – 10%

• • Interviews, screens, and recruits participants for study enrollment.
  • Educates participants on study procedures and expectations.
  • Conducts informed consent for non-interventional studies after verifying eligibility based on protocol criteria.
  • May assist with ordering supplies and equipment necessary for study execution.
  • Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Experience in therapeutics and public health sciences.
• Familiarity with patient interfacing and informed consent processes is highly desirable.
• SOCRA certification is a plus.
• Spanish language certification is helpful.