Human Subject Research Specialist I Ped Allergy

About the Role

Coordinates the activities associated with human subject research in the department of pediatric allergy and immunology.

Key Responsibilities

• Coordinates and supports the administrative and logistical details required to initiate and conduct pediatric allergy and immunology human subject research. This includes receiving, distributing, and explaining study information (protocol and recruitment materials) to subjects, team members, and others.
• Coordinates and supports sample kit preparation and distribution, and processing biospecimens.
• Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients meeting protocol inclusion criteria. May participate in developing recruitment strategies and conduct telephone interviews for screening. Reviews medical chart history with the Principal Investigator to verify atopy diagnoses.
• Conducts study visits to ensure participant adherence with protocol requirements (e.g., medication, biological samples, questionnaires, interventional activities).
• Documents adverse events and reports them to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or other required entities.
• Ensures all data are collected and secured within approved parameters and procedures.
• Works with the Rochester IRB and central IRBs to initiate study protocols, modify procedures, and produce continuing review information.
• Acts as a liaison with the Sponsor’s Monitor to provide data clarifications, review study protocols, ensure thorough understanding and communication, respond to study questions, and communicate/document adverse events as advised by the PI.
• Ensures regulatory and other documents (e.g., consent forms, CRFs) are complete, accurate, and available for review.
• Communicates with Sponsor to clarify data queries and determine report format.
• Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (pre-study inspection, initiation, on-going, and close out).
• Stays current with all federal, state, sponsor, and institutional policies, laws, standard operating procedures, and guidelines, and makes recommendations.
• Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
• Stays current with industry standards, best practices, and trends in therapeutic areas relevant to research studies. Makes recommendations and implements changes as appropriate.
• Other duties as assigned.

Requirements & Tech Stack

• Bachelor's degree required.
• Associate's degree and completion of a 6-month Human Subject Research Coordinator Trainee program required.
• Equivalent combination of education and experience.
• Phlebotomy experience preferred.
• Word processing and data analysis software preferred.
• Excellent organizational skills preferred.

Licenses and Certifications

• CITI GCP and HSP preferred.
• Dry Ice Shipping preferred.