Baylor College of Medicine Department of Pediatrics, Allergy & Immunology Service at Texas Children's Hospital is seeking a highly motivated, responsible, and organized individual to join the Food Allergy Research Program (FAP). The ideal candidate has strong sense of professionalism and leadership skills.

We are seeking to hire a Lead Nurse to work closely with the Clinical Research Manager in supporting the Food Allergy and Asthma Program. This role is essential, as several ongoing and upcoming research trials require clinical procedures that must be performed by a licensed nurse.

Key nursing responsibilities include administering oral food challenge products, performing allergy skin testing, triaging patient calls, placing orders and managing emergency medications on behalf of investigators, and administering investigational products. The Lead Nurse will also take an active role in coordinating and leading studies that specifically require nursing oversight.

In addition to clinical duties, the Lead Nurse will be responsible for overseeing the day-to-day operations of clinical research studies, ensuring that protocols are followed, patient safety is maintained, and study activities run efficiently.

Job Duties

Research Nursing Task/Coordination (60%):

• Assesses eligibility of potential subjects through methods such as screening interviews, review of medical records, and discussion with physicians and nurses.
• Ensures the proper scheduling of subjects for appointments
• Conducts study visits, tests/procedures by study protocols.
• Provides care and monitoring for research participants, monitor for adverse events and report as required, educate participants about study procedures.
• Prepares for and participates in site monitoring visits by sponsors.
• Administers investigational medication and oral food challenge products.
• Obtains vital signs and place orders.
• Triages patient calls including illnesses.
• Oversees studies that require a nurse.

Administrative Support (10%):

• Supports research manager in overseeing research activities.
• Develops, reviews and revises Standard Operating Procedures for research.
• Establishes and maintains internal quality assurance/quality management for research.
• Oversees the proper maintenance of required records of study activities including case report forms, drug dispensation records or regulatory forms.
• Responsible managing and completing key deliverables and critical tasks for complex studies.

Program or Project Support (30%):

• Collaborates with Food Allergy and Asthma Leadership team and faculty to review potential clinical and pre-clinical studies.
• Delegates tasks and ensure effective workflow within the research team.
• Provides training on protocols, lead and manage clinical research studies from study feasibility through close-out.
• Maintains contact with sponsors to schedule and coordinate site visits or answer questions about issues such as incomplete data.
• Serves as a liaison between investigators, sponsors, regulatory bodies, and clinical staff.
• Participates in study planning meetings.
• Assists with strategic planning, evaluation, and assessment.
• Responsible for the creation of required study tools, such as Manual of Operations, source documents, and study orders to ensure seamless operations and accurate data collection activities are appropriately carried out, and regulations/GCP practices are followed.
• Manages overall study conduct under study directives, ensuring subject safety is maintained.
• Provides guidance and mentorship to junior staff members.
• Performs other job-related duties as assigned.

Minimum Qualifications

• Associate's Degree or Bachelor's Degree in Nursing.
• Four years of relevant experience as a licensed Registered Nurse (RN) with a minimum of one year in research nursing.
• Current license as a Registered Nurse (RN) by the State of Texas Board of Nursing.
• Basic Life Support (BLS) Certification from the American Heart Association.