Human Subject Research Specialist

University of Rochester•City of Rochester, NY

7d•$21 - $30•Onsite

About The Position

This position coordinates the activities associated with human subject research in a federally-funded research project studying smoking cessation and physical activity among Latinos. The specialist will serve as a tobacco treatment specialist trained in physical activity and will communicate with study participants in both English and Spanish. The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.

Requirements

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 required
Bilingual in Spanish and English required

Nice To Haves

Word processing and data analysis software preferred

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.
Performs human subject recruitment and screening activities.
Reviews information with Principal Investigator to verify inclusion criteria are met before enrollment.
Conducts visits to ensure research participant adherence with protocol requirements 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.
Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
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