Research Coordinator III - Pediatrics - CRA Neurology Research

Summary

The Research Coordinator III independently manages the day-to-day operations of clinical research studies conducted through the Center for Research Advancement (CRA), supporting the Neurology Division within the Department of Pediatrics. Responsibilities include participant screening and enrollment, study coordination and monitoring, collection and management of research data, and communication with investigators, sponsors, and study participants.

The position is accountable for ensuring the accuracy, integrity, organization, and safety of study-related data and research participants while maintaining compliance with protocol, regulatory, and institutional requirements.This role collaborates closely with Principal Investigators, physicians, and multidisciplinary research teams to implement clinical trial protocols, coordinate study activities, and support ongoing participant follow-up.

The position requires strong knowledge of FDA regulations, Good Clinical Practice (GCP) guidelines, human subjects research protections, and the ability to interpret and apply complex clinical research protocols and study requirements.Operating independently with minimal supervision, the Research Coordinator III manages significant components of large and complex clinical trials or assumes full responsibility for one or more smaller clinical research studies.

The role requires advanced proficiency across all core clinical research coordination functions, including participant recruitment and consenting, protocol implementation, regulatory compliance, investigational product accountability, data management, and study documentation. Success in this position requires sound judgment, attention to detail, and the ability to ensure protocol adherence, data integrity, participant safety, and timely study execution.

Applicants must be willing to work in a fast pace setting, comfortable working in a team environment, and possess excellent communication skills. Position supports multiple complex studies in Pediatrics Neurology Research.

Occasional work on the weekends and after hours may be required.

Job Duties

Clinically and administratively manages multiple complex clinical research studies, including high-volume and rapidly growing studies. Participates in study startup, qualification, and feasibility assessments and provides recommendations to Principal Investigators (PIs) and Research Managers regarding study implementation and operational needs.

Subject Visits – 30%

• Provides protocol-specific education and guidance to research participants within scope of practice.
• Reviews protocols with participants and verifies informed consent documentation before study activities.
• Coordinates protocol-required procedures, laboratory assessments, and study visits.
• Dispenses investigational products and maintains required drug accountability, inventory, and shipment records.
• Collects, processes, stores, and ships biological specimens according to protocols, laboratory procedures, and IATA requirements.

Screening & Enrollment – 20%

• Screens, recruits, and enrolls research participants according to approved protocols and regulatory requirements.
• Interviews participants and evaluates eligibility based on inclusion and exclusion criteria.
• Educates participants regarding study objectives, procedures, risks, benefits, and requirements.
• Facilitates and documents informed consent in accordance with GCP, institutional policies, and applicable regulations.

Data Collection & Entry – 20%

• Collects and manages study data in collaboration with investigators and study team members.
• Obtains data through interviews, questionnaires, laboratory results, and medical record review.
• Enters accurate and complete data into CRFs, electronic data capture systems, and institutional databases.
• Maintains source documentation and study records in compliance with FDA, sponsor, and institutional requirements.

Source Documents & Regulatory Documentation – 15%

• Develops and maintains source documents and study tools supporting protocol execution and data integrity.
• Prepares documentation for regulatory submissions, continuing reviews, amendments, and study closure.
• Maintains regulatory binders, essential documents, and research records.

Sponsor, Participant & Investigator Communication – 15%

• Serves as a primary contact for sponsors, PIs, participants, and collaborating sites regarding study operations.
• Submits SAEs, protocol deviations, and follow-up documentation within required timelines.
• Coordinates communication across investigators, sponsors, regulatory personnel, and participating sites.
• Assists with procurement and inventory of study supplies, equipment, and materials.
• Ensures compliance with FDA GCP guidelines and applicable Baylor College of Medicine, Texas Children's Hospital, and Clinical Research SOPs.
• Performs other 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

• Working knowledge of IRB requirements and Good Clinical Practice (GCP).
• Experience consenting patients, conducting interviews and/or follow‑up with participants.
• Strong organizational skills with the ability to manage high enrollment volumes.
• Excellent interpersonal, communication, and cultural competency skills.
• Ability to work effectively in hospital environments and interdisciplinary teams.
• Willing to lift at least 20-30 lbs.