Human Subj Res Coord Trainee

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

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ESSENTIAL FUNCTIONS

• Assists with 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.
• Tracks regulatory and other documents, such as consent forms and CRFs, and ensures these are complete, accurate and available for review.
• Learns and applies the details of the protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion and adverse event reporting.
• 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, processing biospecimens and conducting telephone interviews to screen potential study candidates.
• Tracks 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.
• Tracks and documents the dispensing and returning of study materials, such as study drugs and devices.
• Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies.

QUALIFICATIONS

• Associate's degree required
• No previous experience required
• Or equivalent combination of education and experience required
• Experience as a Phlebotomist preferred
• Word processing and data analysis software preferred

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 Classes). 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.