University of Rochester
Senior Human Subject Research Specialist
University of Rochester, Rochester, New York, United States
Overview
Senior Human Subject Research Specialist position at University of Rochester. This role manages and oversees activities that establish, monitor and maintain human subject research, including 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. Supervises others up to two employees and ensures compliance with Good Clinical Practices (GCPs) and sponsor requirements. Responsibilities
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 across 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 and effective results. Supports contacts and relationships among Principal Investigators, 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 conducting human subject research in accordance with approved protocols and GCPs, including sponsor policies. Designs, develops, implements, monitors, and manages systems to ensure quality, safety, efficiency, and consistency in data processing; 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 federal, state, sponsor and institutional policies, SOPs and guidelines. Manages and evaluates resulting study changes and 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. Minimum Education & Experience
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 Knowledge, Skills And Abilities
Word processing and data analysis software proficiency. Licenses And Certifications
SOCRA - Certification In Clinical Research upon hire preferred Association of Clinical Research Professionals (ACRP) upon hire preferred The University of Rochester is committed to fostering an inclusive and welcoming culture to advance its Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. The University is an equal opportunity employer and does not discriminate based on age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by law.
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Senior Human Subject Research Specialist position at University of Rochester. This role manages and oversees activities that establish, monitor and maintain human subject research, including 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. Supervises others up to two employees and ensures compliance with Good Clinical Practices (GCPs) and sponsor requirements. Responsibilities
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 across 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 and effective results. Supports contacts and relationships among Principal Investigators, 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 conducting human subject research in accordance with approved protocols and GCPs, including sponsor policies. Designs, develops, implements, monitors, and manages systems to ensure quality, safety, efficiency, and consistency in data processing; 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 federal, state, sponsor and institutional policies, SOPs and guidelines. Manages and evaluates resulting study changes and 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. Minimum Education & Experience
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 Knowledge, Skills And Abilities
Word processing and data analysis software proficiency. Licenses And Certifications
SOCRA - Certification In Clinical Research upon hire preferred Association of Clinical Research Professionals (ACRP) upon hire preferred The University of Rochester is committed to fostering an inclusive and welcoming culture to advance its Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. The University is an equal opportunity employer and does not discriminate based on age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by law.
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