Sr Human Subject Research Spec Job at University of Rochester (Rochester)

Job Description

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.

Job Responsibility

Manages and oversees the activities that establish, monitor and maintain human subject research, including responsibility for ensuring proper staff training
Plans, directs, monitors and coordinates all phases of human subject research, which may include multi-site, community-based research or multiple therapeutic areas
Manages, designs, implements and evaluates study changes
May supervise others up to two employees
Oversees human subject research activities for single or multiple sites
Develops, implements, and evaluates study subject requirement strategies, information and data systems and study management systems
Creates, plans, develops, implements, and manages study design, budgets, protocols, consent forms, processes and policies, including multiple therapeutic areas
Creates, develops, reviews, and approves case report forms and study-specific procedures, manuals and documents
Represents sites, providers, study team, patients, study participants and the University to establish, develop, oversee, monitor, and maintain working relationships, positive communications, and effective results
Responsible for supporting the contacts and relationships between and among Principal Investigators (PI), research staff, study sites, and sponsoring and regulatory agencies
Manages and mentors research coordinators of various levels
Develops, delivers and monitors efficacy of training on the conducting of human subject research in accordance with approved protocols and in compliance with the Good Clinical Practices (GCPs), including training on policies and practices used by sponsors for the purpose of meeting regulatory requirements
Designs, develops, implements, monitors, and manages systems and methods to ensure quality, safety, efficiency, and consistency in the processing of data
Reviews study progress, including data, finances, timeframes, documentation, and reporting deliverables
Manages, implements, and monitors systems for tracking and evaluating study progression
Develops, documents, and implements Standard Operating Procedures (SOPs) at all sites and ensures adherence to established SOPs
Establishes study-specific processes for distribution of study funds
Manages expenses, equipment, and study materials
Prepares and monitors operating and financial reports and documents for review and analysis
Keeps current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines
Manages and evaluates resulting study changes
Demonstrates accountability for continuous learning in accordance with GCPs
Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies

Requirements

Bachelor's degree and 5 years of experience in human subject coordination required
Or equivalent combination of education and experience
Experience as a Phlebotomist preferred
Word processing and data analysis software required
SOCRA - Certification In Clinical Research upon hire preferred
Association of Clinical Research Professionals (ACRP) upon hire preferred

Nice to have

Experience as a Phlebotomist preferred
SOCRA - Certification In Clinical Research upon hire preferred
Association of Clinical Research Professionals (ACRP) upon hire preferred

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Sr Human Subject Research Spec

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