Summary

Position coordinates the activities of clinical trial research studies for the Pediatric Research Resources Office (RRO) / Center for Research Advancement in Pediatric Diabetes & Endocrinology.  Primary responsibilities include patient enrollment, screening, monitoring of research participants, and reporting to the clinical research sponsor. The Research Coordinator II will be responsible for ensuring accurate data collection, documentation, organization and safety of study volunteers. 

The position will serve as a liaison between investigators, sponsors and other relevant healthcare professionals who are part of the research or patient care team.

Job Duties

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.

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.

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/PI's: 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.

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.

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

• Master's degree in a 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. 
• Strong attention to detail and data quality.