Summary

Coordinates day to day activities of clinical trial research studies for the TCH Pediatric Anesthesiology Department. Primary responsibilities include protocols which include patient enrollment, screening, monitoring of research participants, and reporting to the clinical research sponsor and Principal Investigators. The Research Coordinator II will be responsible for ensuring accurate data collection, documentation, organization and safety of study volunteers. This position will be working directly with physicians and investigators at Texas Children’s Hospital to enroll and follow up on study patients.  
 

Job Duties

• Interviews, screen and recruits patients for enrollment in studies. 
• Performs the subject consent process of patients.
• Conducts subject research study education as required within the scope of practice.
• Collect and record study data related to individual studies. 
• Collects patient information and enter into database. 
• May collect, process, ship, and maintain paperwork for blood and/or biological specimens. 
• Maintains records and regulatory documents and records for research studies.
• May assist with the supply orders and equipment necessary for the study.
• Interviews, screen and recruits patients for enrollment in studies; explains process and procedures to educate participant 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.
• Conducts subject research study education as required within the scope of practice.
• Discusses study protocols with patients and verifies the informed consent documentation.
• Responsible for assisting the Principal Investigator with collecting and/or recording study data related to individual studies. This may include pre/intra/postop vital signs, scales/scores for pain, nausea. 
• 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 electronic medical chart abstractions; processes documents and enters information into databases or case report forms.
• Build and manage databases according to study protocols. Database entry can be through various methods and REDCap is the primary database at TCH.
• May collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol.
• Maintains records and regulatory documents and records for research studies.
• Meets with Principal Investigators and Research Supervisor, operating independently, or with only minimal guidance. 
• Submits serious adverse event reporting and follow up as needed.
• 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 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

• Master's degree in a related field. 
• One year of clinical research experience.
• Strong oral and written communication skills, ability to work on a team and independently; organized, takes initiative; professional, will communicate with staff, faculty, nursing staff, patients and families.  
• Ability to adapt to the diverse departmental research needs.