Sr Human Subject Research Spec
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: 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. ESSENTIAL FUNCTIONS 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. Other duties as assigned.
Requirements
- Bachelor's degree and 5 years of experience in human subject coordination required
- Or equivalent combination of education and experience
- Word processing and data analysis software required
Nice To Haves
- Experience as a Phlebotomist preferred
- SOCRA - Certification In Clinical Research upon hire preferred
- Association of Clinical Research Professionals (ACRP) upon hire preferred
Responsibilities
- 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.
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
