Human Subject Research Specialist I

About the Role

The Human Subject Research Specialist I coordinates the activities associated with human subject research at the University of Rochester.

Key Responsibilities

• Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing, and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others.
• 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. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.
• Conducts visits to ensure research participant adherence with protocol requirements, such as taking of medications, proper use of device, 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 all data are collected and secured within approved parameters and procedures.
• Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures, and standards for documentation and communication. Under general direction from the Principal Investigator (PI), trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion, and adverse event reporting.
• Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
• 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, such as 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.

Requirements & Tech Stack

• Word processing and data analysis software preferred.

Qualifications

• 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