University of Rochester Advancement · 3 months ago
Human Subject Research Spec I
Wilmot
Full-time
Onsite
New Grad, Entry Level
$21.36/hr - $29.90/hrThe University of Rochester is dedicated to fostering an inclusive community and is seeking a Human Subject Research Specialist I. This role involves coordinating activities associated with human subject research, assisting in recruitment and screening, and ensuring compliance with protocols and regulations.
Higher Education
Responsibilities
Coordinates the activities associated with human subject research
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
Qualification
Required
Bachelor's degree required
Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required
Or equivalent combination of education and experience
Preferred
Prior experience as a Phlebotomist
Word processing and data analysis software
Company
University of Rochester Advancement
The University of Rochester, one of the nation’s top private research universities, has built a national caliber advancement program in support of the largest campaign in the University’s history.
Founded in 1946
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase