Summary

Baylor College of Medicine, Department of Pediatrics, Immunology, Allergy and Retrovirology Service at Texas Children’s Hospital is seeking a highly motivated, responsible, and organized individual to join the Food Allergy Research Program (FAP) as a Research Assistant.  The Research Assistant I will be responsible for extracting data from medical records and data entry into REDCap. The Research Assistant will be responsible for coordinating and overseeing day-to-day activities of research protocols for the Penicillin Allergy Clinic and Food Protein-Induced Enterocolitis Syndrome (FPIES) Clinic. Additionally, the Research Assistant will be responsible for processing, storing, documenting and shipping blood samples collected from patients on research studies. The research assistant will ensure accurate data collection, documentation, organization and safety of research participants. The research assistant will work closely with the investigators, study team, and regulatory staff to ensure the research studies are performed in accordance with federal regulations, sponsor guidelines, and departmental policies. Strong organizational skills are required to coordinate events such as patient/family engagement activities and organize and conduct team meetings.

Job Duties

Study Management / Clinical and Research Assistance 

• Manage daily operations of the Penicillin allergy and FPIES studies
• Interface with research subjects with the purpose of recruitment, screening and enrollment
• Responsible for randomization, sample collection, sample processing and shipping
• Administer questionnaire forms, extract data from medical records
• Review study materials to ensure compliance with the IRB approved protocols and monitor research patients
• Ensure accurate data collection, documentation, organization and safety of research participants
• Evaluate subjects for study eligibility and continued participation in the study
• Responsible for processing, storing, documenting and shipping blood samples collected from patients on research studies

Project Management 

• Interact with research study team
• Work with regulatory team to ensure compliance with research
• Knowledgeable in documenting study information per protocol
• Perform QA/QC of study binders in preparation for audits and ensure accurate data collection

Patient Liaison and Advocacy 

• Educate patients, families and clinic staff on research staff and procedures
• Promote education awareness for patients, families and community
• Discusses trials with patients, obtains informed consent, and enrolls patients
• Schedule and coordinate advocacy related events such as patient/family engagement activities, which include an annual Food Allergy Symposium
• Corresponds with patients throughout the study
• Serve as a liaison between the community and PIs

 Other duties:

• Collect patient information; process documents and enter information into a database
• Maintain records and regulatory documents and records for research studies
• Schedule research participant for tests and procedures such as laboratory tests and other studies specific for the research protocol
• Order supplies and equipment
• Evaluate and analyzes clinical research data
• Prepare documentation necessary to obtain initial and continued approval for the specific research protocol
• Perform literature searches and prepare literature reviews
• Organize and conduct meetings and phone conferences regarding new and current protocols
• Conduct chart review to identify research participants
• Generate data report to determine feasibility for upcoming studies
• Maintain and organize inventory of study supplies

Minimum Qualifications

• Bachelor's degree in a Basic Science or a related field.
• Two years of relevant experience.

Preferred Qualifications

• Master's degree in a related field.
• Strong organizational skills are required to coordinate events such as patient/family engagement activities and organize and conduct team meetings.
• Experience with RedCap