Human Subject Research Specialist I Ped Allergy
About The Position
Coordinates human subject research activities in the Department of Pediatric Allergy and Immunology. Supports the administrative and logistical requirements for initiating and conducting research, including communicating study information and recruitment materials to participants and relevant team members; preparing and distributing sample kits; and processing biospecimens. Assists with recruitment and screening, conducts study visits, monitors participant adherence to protocols, documents adverse events, and ensures research data are collected and secured according to approved procedures. Works with institutional and central review boards to initiate and modify protocols and prepare continuing-review materials. Serves as a liaison with sponsor monitors, supports monitoring visits, resolves data queries, and ensures study documents are complete and available for review. Maintains knowledge of applicable policies, laws, procedures, Good Clinical Practice standards, and relevant research-industry practices.
Requirements
- Bachelor's degree; or an associate's degree and completion of six months in the Human Subject Research Coordinator Trainee program; or an equivalent combination of education and experience.
Nice To Haves
- Prior experience as a phlebotomist.
- Word processing and data analysis software skills.
- Excellent organizational skills.
- CITI GCP and HSP certification.
- Dry Ice Shipping certification.
Responsibilities
- Coordinate and support administrative and logistical activities required to initiate and conduct pediatric allergy and immunology human subject research.
- Receive, distribute, and explain study information, including protocols and recruitment materials, to study subjects, team members, and other relevant parties.
- Coordinate sample-kit preparation and distribution and process biospecimens.
- Assist with recruitment and screening, including reviewing patient databases and office records, developing recruitment strategies, conducting telephone screening interviews, and reviewing medical chart history with the Principal Investigator to verify atopy diagnoses.
- Conduct study visits and support participant adherence to protocol requirements, including medication-taking, biological-sample collection, questionnaire completion, and other interventions.
- Document adverse events and report them to senior study staff, the Principal Investigator, the IRB, sponsors, or other required recipients.
- Ensure research data are collected and secured within approved parameters and procedures.
- Work with the Rochester IRB and central IRBs to initiate protocols, modify study procedures, and prepare continuing-review information.
- Liaise with sponsor monitors, clarify data queries, review protocols, respond to study questions, communicate and document adverse events as advised by the Principal Investigator, and ensure regulatory and other documents are complete and accurate.
- Prepare for, participate in, and serve as liaison during sponsor monitoring visits, including pre-study inspection, initiation, ongoing, and close-out visits.
- Keep current with applicable federal, state, sponsor, and institutional policies and laws, standard operating procedures, guidelines, Good Clinical Practice standards, and relevant industry practices; recommend and implement changes as appropriate.
- Perform other duties as assigned.
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What This Job Offers
Career Level
Entry Level
