Human Subject Research Coordinator Trainee

at  University of Rochester

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 a culture of equity, diversity, and inclusion 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 status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

GENERAL PURPOSE:

Assists with the activities associated with human subject research.

RESPONSIBILITIES:

• 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.
  Other duties as assigned