Summary

The Research Coordinator II coordinates and manages the day-to-day activities of clinical research studies within the Center for Research Advancement, supporting the Pediatric Diabetes & Endocrinology division. Primary responsibilities include participant recruitment and enrollment, eligibility screening, study visit coordination, ongoing participant monitoring, data collection and documentation, and reporting to study sponsors. The position is responsible for ensuring protocol compliance, maintaining accurate research records, safeguarding participant safety, and supporting the successful conduct of studies throughout the research lifecycle.

The Research Coordinator II works closely with principal investigators, physicians, sponsors, and multidisciplinary healthcare teams to facilitate the implementation and execution of clinical research protocols. Serving as a liaison among investigators, sponsors, research staff, and clinical care teams, this role supports the treatment, follow-up, and retention of study participants. The position requires knowledge of FDA regulations, Good Clinical Practice (GCP) guidelines, and research compliance requirements, as well as the ability to interpret and apply complex protocol, regulatory, and study-related information. 

This position will be working directly with physicians and investigators to treat and follow up on study patients. The position adheres to FDA Good Clinical Practice standards governing the design, conduct, monitoring, documentation, analysis, and reporting of clinical research, and complies with Baylor College of Medicine, Texas Children’s Hospital, and Clinical Research Standard Operating Procedures (SOPs). 

Job Duties

Subject Visits: 30% of Duties

• Conducts subject research study education as required within the scope of practice.
• Discusses study protocols with patients and verifies the informed consent documentation.
• Dispenses study medication in a professional and accountable manner following protocol and hospital requirements.
• Collects, processes and stores or ships blood or biological specimens as outlined per study protocols and associated lab or procedural manuals, in accordance with IATA Guidelines. 

Screening & Enrollment: 20% of Duties

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

Data Collection & Entry: 20% of Duties

• Responsible for assisting the Principal Investigator with collecting and recording study data related to cauterization procedures, cardiac measurements, and related test and measurement for the study.
• Collaborates with physician, mid-level practitioners, and research nurses and data managers to document patient care.
• Collects patient information through direct patient interviews, questionnaires, and chart abstractions; processes documents and enters information into databases or case report forms.
• Collects research patient information (i.e., medical history, labs) from the electronic medical record (EMR).
• Maintains study records and regulatory documents for research studies.
• Submits data, study documents, and/or reports to regulatory agencies.
• Maintains accurate source documentation and case report forms (CRFs) per protocol.
• Submits accurate research data via CRF to external sources.
• Monitors protocol compliance and appropriately communicates errors or deficient source documentation. 

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

• Prepares documentation necessary to obtain initial and continued approval for the specific research protocol.
• Oversee study-related documentation. 

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

• Meets with Principal Investigators; with direction from the Principal Investigator, provides appropriate and timely responses to research team, study participants, and sponsor data requests or queries, and external or internal audits.

Other

• May assist with the supply orders and equipment necessary for the study.
• Adheres to FDA Good Clinical Practices outlining the standard 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 
• 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.
• One year of relevant experience.

Preferred Qualifications and Skills

• Bachelor's degree in healthcare, public health, or scientific related field.
• Ability to understand the complexities of clinical trials and research protocols, including issues related to informed consent, access to data, and conflict of interest. 
• Applicants must be willing to work in a fast pace setting, comfortable working in a team environment, and possess excellent communication skills.
• Bilingual in Spanish.
• Experience with Epic.
• Experience with REDCap.