Sr Human Subject Research Specialist

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.

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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. Directs the development and execution of research activities for multicenter funded national and international research studies. 
• Liaises with Data management center at sites external to URMC, resolve queries of multiple sites, edit the study database, and analyze data. Serves as primary contact with data managers to obtain relevant subject data such as enrollment numbers and adverse events
• 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 compliance with regulatory and institutional requirements and designs systems and processes to monitor and document routing audits for divisional studies. Serves as the liaison to sponsor study monitors.  Coordinates and attends monitor meetings according to protocol.  Prepares for and participates in schedules sponsor monitoring visits.  Builds relationships with sponsors, advocacy groups, community and institution to assist with strategic growth of the division’s research.
• 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.  Trains and oversees other divisional human subjects research coordinators on protocol, procedures, new test/surveys, and other institutional and sponsor 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. Tracks and monitors metrics associated with study start up, recruitment, enrollment, protocol violations, adverse events, amendments, regulatory filings, etc. for the division. 
• Develops, documents, and implements Standard Operating Procedures (SOPs) at all sites and ensures adherence to established SOPs. Writes and maintains protocols and associated documentation such as enrollment forms, eligibility checklists, adverse event reporting forms and case report forms.  Ensures integrity of all study data collected.  Serves as the liaison to sponsor study monitors.  Coordinates and attends monitor meetings according to protocol.  Prepares for and participates in schedules sponsor monitoring visits. 
• Oversees and coordinates with investigators on grant preparation and submission of grant content assembly for study manuals, procedural manuals, and manuals of operation. 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.  Coordinates and monitors financial data and spend categories for budget and variance reporting, and for compliance with all institutional requirements for adequate system controls.  Reports variances to research administrator.
• 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.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 5 years of experience in human subject coordination required
• Master’s in Health Science Related Field preferred
• Or equivalent combination of education and experience
• Experience as a Phlebotomist preferred
• Experience in human subject research coordination for Neurologic Disorders preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of word processing and data analysis software required

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, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of 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 federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.