Human Sub Research Spec I

University of Rochester•Town of Henrietta, NY

4d•$21 - $30

About The Position

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. Under general direction, this individual will have responsibility for planning, coordinating and carrying out recruitment, scheduling, enrollment, study visits, and data collection for assigned clinical research studies. Supports daily operations for research studies and clinical trials as needed while meeting regulatory, University and sponsor requirements. While the work will be carried out under general supervision, the HSRC will work independently and complete study procedures with human subjects independently.

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
Word processing and data analysis software

Nice To Haves

Experience as a Phlebotomist preferred

Responsibilities

Assists in recruitment efforts to ensure research studies are fully enrolled.
Maintaining HIPAA and Human Subject Protection compliance, collects, classifies and documents patient information and makes recommendations about the most appropriate, currently enrolling AIR study a given patient should enroll in.
With oversight, conducts recruitment and screening activities to identify eligible research candidates, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria and/or being present in clinic to assist Principal Investigators with recruitment and enrollment.
Conducts telephone interviews to screen potential study candidates.
Consents subjects for data and tissue collection studies.
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, Principal Investigator (PI), Institutional Review Board (IRB), Sponsor and/or any other required recipients or entities; and to ensure all data are collected and secured within approved parameters and procedures.
Consents and enrolls subjects into AIR contact database/repository study.
Assists with data entry as needed.
Performs essential liaison function between Principal Investigators, the study team and patients.
Prepares reports by collecting data on enrollment progress and presents to Clinical Research Manager, Sr. HSRC and/or Sponsor Monitor on a regular basis.
Represents the Principle Investigator at appropriate meetings regarding clinical trials.
Coordinates the administrative details required to initiate and conduct human subject research, such as, creating, receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials (i.e., brochures, advertisements, newsletters, consents etc.) to immediate team members, eligible study candidates and relevant others.
Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.
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