Summary

The Senior Research Coordinator clinically and administratively manages multiple studies and complex clinical trials in the Department of Pediatrics, Center for Research Advancement. Primary responsibilities include patient enrollment, screening, monitoring of research participants, ensuring compliance, and reporting to the clinical research sponsor. The Senior Research Coordinator should be able to independently lead the day-to-day operations of a complex clinical research study and will be responsible for ensuring accurate data collection, documentation, organization, and the safety of study volunteers.

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

This position supports studies in Pediatrics, including Endocrinology, Nephrology, and Gastroenterology, within the Center for Research Advancement.

Job Duties

Clinically and administratively manages multiple studies involving rapid scale-up and a high volume of patients/participants in a complex clinical trial. Participates in study feasibility by completing a comprehensive review of the protocol and study logistics such as staffing resources, patient population, and clinical resources needed to correctly conduct the study.

Screening & Enrollment: 20% of Duties

• Interviews, screens, and recruits patients for enrollment in studies.
• Explains processes and procedures to educate participants regarding the research study.
• Performs the subject consent process after verifying eligibility based on comprehensive inclusion and exclusion criteria outlined in the protocol.

Subject Visits: 30% of Duties

• Conducts subject research study education as required within the scope of practice.
• Discusses study protocols with patients and verifies informed consent documentation.
• Dispenses study medication in a professional and accountable manner, following protocol and hospital requirements.

Data Collection & Entry: 20% of Duties

• Responsible for assisting the Principal Investigator with collecting and recording study data related to catheterization procedures, cardiac measurements, and related tests and measurements for the study.
• Collaborates with physicians, mid-level practitioners, research nurses, and data managers to document patient care.
• Collects patient information through direct interviews, questionnaires, and chart abstractions; processes documents and enters information into databases or case report forms.
• Responsible for electronic case reporting requirements in accordance with all FDA and clinical trial study requirements.
• Manages and enters study information into the CTMS (Clinical Trial Management System) database.

Source Document/Document Review & Development: 15% of Duties

• Prepares documentation necessary to obtain initial and continued approval for the specific research protocol.
• Oversees study-related documentation. Reviews protocol documents, including abstracts, text, and informed consent for relevant information.
• Evaluates and analyzes clinical research data as appropriate. Generates reports and presents data analysis.

Communication with Sponsor/Subjects/PIs: 15% of Duties

• Meets with Principal Investigators and Study Sponsors, operating independently or with only minimal guidance.
• Interacts with sponsors and/or coordinating sites as required to facilitate protocol activities and maintains current study documents.
• Submits serious adverse event reports and follow-up as needed.
• Performs other job duties as assigned.

Adheres to FDA Good Clinical Practices outlining the standards for safety, design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies.

Adheres to Baylor College of Medicine, Texas Children's Hospital, and Clinical Research SOPs.

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

• 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