Human Subject Research Specialist II

University of Rochester

2d • $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. With considerable latitude for independent judgment, coordinates all aspects of assigned human subject research studies involving Spanish-speaking patients for the department of Neurology Movement Disorders division. Typically, responsible for the successful coordination of complex interventional or large multi-site clinical drug trials. Receives delegation of study tasks from multiple Principal Investigators and works as an integral part of the research team. May provide mentorship to Human Subject Research Specialist I.

Requirements

• Bachelor’s degree required
• 2 years of experience in human subject research coordination required or equivalent combination of education and experience
• Word processing and data analysis software required

Nice To Haves

• Fluent in the Spanish language (verbal & written) preferred
• Knowledge of word processing, spreadsheets, Red Cap and electronic data capture (EDC) software preferred
• Experience as a Phlebotomist preferred
• Excellent communication skills, strong attention to detail, and strong interpersonal skills preferred
• Ability to work independently and as part of a team preferred
• SOCRA - Certification In Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred

Responsibilities

• Study Visits: Recruits, consents, schedules, and conducts research subject visits for complex studies (i.e., industry-sponsored clinical drug trials involving greater risk to subjects) in accordance with study protocol, coordinating these visits with the Principal Investigator. Develops, implements, and evaluates subject recruitment and retention strategies. Consents subjects to assigned research studies Schedules and facilitates visits, performing study related procedures as outlined in protocol Draws blood and performs testing such as ECG, timed mobility tests, and cognitive function tests, depending on the protocol Coordinates and documents dispensing and returning of study drugs/materials Meets with Spanish-speaking patients interested in research after their clinical visit to discuss research opportunities Assists Spanish-speaking patients with research visit appointment confirmation and transportation facilitation
• Mentoring: Mentors and trains Human Subject Research Specialist I (HSRS I) on activities related to conducting human subject research. Provides study-specific training, oversight, and back-up support. Trains on federal, state, sponsor, and/or institutional regulations, policies, and practices related to human subject research. Mentors on activities specific to conducting research for complex studies. Completes annual performance evaluations/reviews for HSRS I.
• Regulatory Oversight: Oversees and manages the regulatory details for multiple assigned research studies. Creates, modifies, organizes, and maintains study documentation for the regulatory file Manages and submits study applications, amendments, and continuing reviews for IRB approval Ensures compliance with all applicable regulatory and institutional requirements and standards Ensures the integrity and security of all study documents at all times Initiates, monitors, and ensures that regulatory activities are standardized across studies. Implements immediate and appropriate corrective action when inconsistency of activities is identified
• Liaison: Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolves issues, and enhance collaboration. Maintains continuous communication with all relevant stakeholders. Troubleshoots and resolves issues in a timely manner Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol Represents the University and Principal Investigator at study meetings as needed
• Data Management: Develops and/or manages databases (e.g., EDC) for research studies. Develops, implements, and monitors systems and methods to ensure data integrity Ensures data is entered in a timely manner and database(s) is up to date Responds to queries resulting from research visits in a timely manner, ensuring all issues are resolved Exports research data used for analysis and preparation of presentations, abstracts, and publications
• Continuing Education: Demonstrates accountability for continuous learning related to clinical research. Keeps current with study-specific training, including understanding specific details of study protocol, all relevant sponsor and institutional policies, standard operating procedures, and guidelines Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and state polices and laws, institutional certifications, industry standards and best practices, and trends in relevant therapeutic areas. Attends division and research meetings Attends and leads talks with community groups such as the Ibero-American Action League Participates in Ibero’s community advisory board Partners with the Latino Health Coalition
• Other duties as assigned.

What This Job Offers

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