Human Subject Research Specialist I Ped Allergy

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• Coordinates and supports the administrative and logistical details required to initiate and conduct pediatric allergy and immunology human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to study subjects, immediate team members, and relevant others.
• Coordinates and supports sample kit preparation and distribution, and processing biospecimens, as part of pediatric allergy and immunology human subject research.
• Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria.  May participate in developing recruitment strategies for allergy patients and children/adults without allergies.  May conduct telephone interviews to screen potential study candidates.  Reviews medical chart history with Principal Investigator to verify atopy diagnoses.
• Conducts study visits to ensure research participant adherence with protocol requirements, such as taking of medications, collection of biological samples, completion of REDCap questionnaires, and/or other interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities.  Ensures that all data are collected and secured within approved parameters and procedures.
• Works with the Rochester IRB (Click) and central IRB's, when appropriate, to initiate study protocols, modify study procedures, and produce continuing review information for any assigned studies.
• Acts as liaison with Sponsor’s Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review.  Communicates with Sponsor to clarify data queries to determine report format.  Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on-going and close out visits).
• Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines and makes recommendations.  Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.  Keeps 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

• Bachelor's degree required or
• Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required
• Or equivalent combination of education and experience
• Prior experience as a Phlebotomist preferred

• Word processing and data analysis software preferred
• Excellent organizational skills preferred

• CITI GCP and HSP preferred
• Dry Ice Shipping preferred

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