Human Subjects Research Coordinator- II

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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Engagement and monitoring of study subjects:

• Oversee and coordinate human subject research activities for UofR Study site. Develops and implements and evaluates recruitment strategies and study management systems. Participates in the development of consent forms and study design policies. Participates in the review and upkeep of study-specific procedure manuals and documents. Schedule and conduct study visits, consenting participants and explaining study protocols to ensure patient compliance. Works independently with input from the PI. Is responsible for subject tracking, administering the study vitamin D on the first study day, drawing blood, processing biological sampling, ensuring form completion, and adherence to protocol.
• Assist in developing protocol with PI, recruitment strategies, and monitors target enrollment numbers. Inform Cornell study team when subjects complete study and need to be reimbursed. Interface with PI at Cornell to update on enrollment status and any issues that arise during the study.
• Study administration, participates in advertising material development, and coordination of study with PI. Is solely responsible for the day-to-day operations of the study and must use independent judgment. Represents study team to maintain positive communication and relationships among the PIs, research staff and sponsoring and regulatory agencies.

Information Management:

• Completes interviews and phone calls with subjects as required by protocol.
• Completion of source documents: CRFs, follow-up phone calls, and subject mailings.
• Provide collection, labeling, and coordination of study specimens to be delivered to the core laboratory; ensure labeling is correct and coordinate sample shipments to Cornell.
• Perform chart reviews and information abstraction/recording, phone communications with subjects, fax/mail as necessary as pertains to enrolled subjects at your site.
• Perform data entry and integrity checks; enter data into web-based database and respond to sponsor data queries as they arise. 
• Interface with study monitors to answer any questions and keep complete regulatory and subject documentation.

Research Team Collaboration:

• Coordinate with the PI, the sponsor, and the data monitors to ensure regulatory and other documents are complete and on time.
• Attend team meetings and conference calls as needed.

• Bachelor's degree and 2 years of experience in human subject research coordination required
• Or equivalent combination of education and experience
• Experience as a Phlebotomist preferred

• Word processing and data analysis software required
• Knowledge of Microsoft Office and Windows software preferred. 
• Experience with data entry or management preferred.

• Must be able to work occasional weekends and in late afternoons/early evenings on some weekdays.  

• SOCRA - Certification in Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred

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