Sr Human Subject Research Spec

001 University of Rochester; City of Rochester (NY); On-site; USD 61,000 - 85,000; Full time

Job summary

The University of Rochester is seeking a dedicated Research Coordinator to manage and oversee human subject research activities. You will ensure staff training, compliance with GCPs, and coordination across sites and sponsors.

Responsibilities include designing study procedures, monitoring progress, and mentoring coordinators while maintaining SOPs and regulatory requirements. A strong background in research operations is essential.

Qualifications

• Bachelor's degree and 5 years of experience in human subject coordination required.
• Phlebotomist experience preferred.

Responsibilities

• Oversees human subject research activities for single or multiple sites.
• Develops, implements and evaluates study changes and SOPs.
• Plans, directs, monitors and coordinates all phases of human subject research.
• May supervise others up to two employees.
• Responsible for supporting contacts between PIs, staff, sites, and sponsors.

Skills

Word processing

Data analysis

Education

Bachelor's degree

5 years experience in human subject coordination

Tools

SOCRA Certification

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 Location (Full Address): 601 Elmwood Ave, Rochester, New York, United States of America, 14642

Worker Subtype: Regular Time Type: Full time Scheduled Weekly Hours: 40 Department: 400098 General Neurology Unit Work Shift: UR - Day (United States of America) Range: UR URG 110 Compensation Range: $61,000.00 - $85,400.00. The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities

• 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.

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 required

Licenses and Certifications

• SOCRA - Certification in Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred

Diversity and Inclusion Statement

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.

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About the University

Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries - always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better. If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals.

At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better - Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.