Summary

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

This position will be working directly with physicians and investigators to review treatment protocols and follow up on study patients.  Candidates must have a working knowledge of FDA Good Clinical Practices, and the ability to read, analyze, and interpret information. Position at this level operates independently, or with only minimal guidance, the significant and key aspects of a large clinical trial or all aspects of one or more smaller clinical trial or research project.  

This position is able to execute all the key functions of clinical research coordination job role. This position will be working directly with physicians and investigators to treat and follow up on study patients. Must have a working knowledge of FDA Good Clinical Practices, and the ability to read, analyze, and interpret information.

Job Duties

Clinically and administratively manages multiple studies involving rapid scale up and a high volume of patients/ participants in complex clinical trials. Participates in study qualification and study feasibility activities for report to Principal Investigators and Research Managers.

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. 
• Schedules research participants for tests and procedures such as laboratory tests and other studies specific for the research protocol. Explains processes and procedures to educate the participants regarding the respective research study. 
• Dispenses study medication in a professional and accountable manner following protocol and hospital requirements. -Maintains investigational drug dispensing accountability and shipping logs according to protocol guidelines.
• 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.
• Maintains records and regulatory documents and records for respective research studies to ensure compliance with FDA and other regulatory entities. 

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 and Study Sponsors, operating independently, or with only minimal guidance. 
• Submits serious adverse event reporting and follow up as needed.
• Facilitates study related communication across centers.
• 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.
• Two years of relevant experience.

Preferred Qualifications

• Master's degree in a related field.
• Experience managing multiple studies involving rapid scale up and a high volume of patients/ participants in complex clinical trials.
• Must be willing to work in a fast pace setting, comfortable working in a team environment, and possess excellent communication skills.