University of Rochester Advancement · 2 months ago
Human Subject Research Spec II
Rochester - NY
Full-time
Onsite
Entry, Mid Level
$52K/yr - $73K/yr
2+ years expThe University of Rochester is committed to advancing its mission of learning and discovery, and they are seeking a Human Subject Research Specialist II to coordinate human subject research activities. This role involves overseeing research activities, developing recruitment strategies, ensuring compliance with regulations, and maintaining effective communication among all stakeholders involved in the research process.
Higher Education
Responsibilities
Oversees and coordinates human subject research activities for single or multiple sites
Develops, implements, and evaluates recruitment strategies, information, data systems, and study management systems
Participates in the planning, development, and implementation of study design, budgets, protocols, consent forms, processes, and policies, including multiple therapeutic areas
Participates in the development, review, and approval of case report forms (CRFs) and study-specific procedure manuals and documents
Represents sites, providers, study team, patients, study participants, and the University to develop, monitor, and maintain working relationships, positive communications, and effective results with regard to the coordination of human subject studies
Supports the contacts and relationships between and among Principal Investigator (PI), research staff, study sites, and sponsoring and regulatory agencies
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, including data, finances, documentation, and reporting deliverables
Designs, develops, implements, monitors, and manages systems and procedures to track study progression
Ensures compliance with all applicable regulatory and institutional requirements and standards
Ensures the integrity and security of all study data at all times. Initiates, monitors, and ensures all protocol activities are standardized across study sites. Implements immediate and appropriate corrective action when inconsistency of activities is identified
Trains research coordinators and other staff on activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements
May direct the activities of subordinate staff and others to gather, compile, and analyze study information
Coordinates and monitors financial data for budget and variance reporting and compliance with all institutional requirements for adequate system controls
Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines
Demonstrates accountability for continuous learning in accordance with GCP 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
Other duties as assigned
Qualification
Required
Bachelor's degree and 2 years of experience in human subject research coordination required
Or equivalent combination of education and experience
Word processing and data analysis software required
Preferred
Experience as a Phlebotomist
SOCRA - Certification In Clinical Research upon hire
Association of Clinical Research Professionals (ACRP) upon hire
Company
University of Rochester Advancement
The University of Rochester, one of the nation’s top private research universities, has built a national caliber advancement program in support of the largest campaign in the University’s history.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase