Human Sub Research Spec II

University of Rochester • City of Rochester, NY

11d • $25 - $35 • Onsite

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. GENERAL PURPOSE This position provides coordination for a research study in the URMC Psychiatry Department and entails coordinating, directly conducting, and supervising all stages of human subject's research from recruitment to follow-up, interacting with research participants, and supervising student RAs. Coordinates human subject research activities which may include multiple site human subject studies. Will provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. The HSRC II will be in charge of the student RAs and will train them. Will be required to work 40 hours a week, one evening a week, one Saturday a month will be required.

Requirements

• Bachelor’s degree Required
• 2 years of experience in human subject research coordination Required
• or equivalent combination of education and experience Required
• Word processing, Excel, and data analysis software (e.g., SPSS) Required

Nice To Haves

• Experience as Human Subject Research Coordinator Preferred
• Professional Research Coordinator Certification (SoCRA or ACRP) Preferred
• - SOCRA - Certification In Clinical Research upon hire preferred
• - Association of Clinical Research Professionals (ACRP) upon hire preferred

Responsibilities

• Participant recruitment and enrollment: Oversees, coordinates and conducts human subject research activities for single or multiple sites. Recruits and enrolls participants. Is required to work one evening a week and one Saturday per month.
• Recruitment strategies and materials: Develops, implements and evaluates recruitment strategies, materials, information and data systems, as well as study management systems.
• Participant retention: Follows up with study participants regarding assessments and document communications, including protocol deviations.
• Supervisory duties: Trains research staff (e.g., student RAs; new fulltime staff) about activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements. Directs the activities of subordinate staff and relevant others to gather, compile and analyze study information.
• Data Management: Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Reviews study progress, conducts data quality checks monthly, ensures data files are updated in a proper timeframe, codes data, cleans data, creates databases for manuscript preparation.
• Regulatory: Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs, implements and monitors resulting study changes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level