Summary

The Research Coordinator III manages the day‑to‑day activities of clinical research studies conducted through the Center for Research Advancement, primarily supporting the Renal Division in the Department of Pediatrics. Responsibilities include patient screening and enrollment, participant monitoring, study data collection and documentation, and reporting to clinical research sponsors, with accountability for the accuracy, integrity, organization, and safety of all study‑related data and research participants.

This role collaborates closely with physicians and investigators to review and implement clinical trial protocols and to conduct ongoing follow‑up with study participants. The position requires a working knowledge of FDA Good Clinical Practice (GCP) guidelines and the ability to read, analyze, and interpret complex clinical research information.

Operating independently or with minimal supervision, the Research Coordinator III is responsible for managing key components of a large clinical trial or all aspects of one or more smaller clinical trials or research projects. The role requires advanced knowledge of human subjects research and GCP‑aligned consenting practices, and full proficiency across core clinical research coordination functions to ensure protocol fidelity, data integrity, 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.

Job Duties

Clinically and administratively manages multiple complex clinical research studies involving rapid scale‑up and high patient/participant volumes. Participates in study qualification and feasibility assessments and prepares analyses and recommendations for Principal Investigators and Research Managers.

Screening & Enrollment – 20%

• Screens, recruits, and enrolls patients/participants into research studies in accordance with approved protocols.
• Conducts participant interviews and verifies eligibility based on comprehensive inclusion and exclusion criteria.
• Educates participants on study purpose, procedures, risks, and requirements, and conducts the informed consent process in compliance with GCP and institutional policies.

Subject Visits – 30%

• Provides study‑specific education to research participants within scope of practice.
• Reviews study protocols with participants and verifies informed consent documentation prior to study activities.
• Schedules participants for protocol‑required tests and procedures, including laboratory assessments and study‑specific evaluations.
• Dispenses investigational study medication in accordance with protocol requirements and institutional policy, maintaining complete drug accountability and shipping records.
• Collects, processes, stores, and ships blood and biological specimens per protocol, laboratory manuals, and IATA guidelines.

Data Collection & Entry – 20%

• Collects, documents, and records study‑related data in collaboration with the Principal Investigator, physicians, advanced practice providers, research nurses, and data managers.
• Obtains patient information through direct interviews, questionnaires, and medical record abstraction; enters data into case report forms and electronic databases.
• Maintains accurate source documentation, study records, and regulatory files to ensure compliance with FDA and other applicable regulatory requirements.

Source Document Development & Review – 15%

• Prepares and maintains documentation required for initial and continuing regulatory approval of assigned research protocols.
• Oversees the development, organization, and maintenance of study‑related source and regulatory documentation.

Communication with Sponsors, Subjects, and Investigators – 15%

• Communicates independently, or with minimal guidance, with Principal Investigators and study sponsors regarding study operations and status.
• Submits serious adverse event reports and follow‑up documentation as required.
• Facilitates study‑related communication across participating sites and centers.
• Assists with ordering and coordination of study‑related supplies and equipment as needed.
• Adheres to FDA Good Clinical Practice (GCP) standards and all Baylor College of Medicine, Texas Children’s Hospital, and Clinical Research SOPs governing the conduct of clinical research.
• 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

• Master's degree in healthcare administration
• 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.