Sr Human Subject Research Spec at University of Rochester

City of Rochester, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Oct, 26

Salary

85400.0

Posted On

12 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Human Subject Research Management, Clinical Trial Coordination, Budget Management, Protocol Development, Regulatory Compliance, Staff Training, Data Analysis Software, Word Processing, Phlebotomy, SOP Development, Case Report Forms, Quality Assurance

Industry

Higher Education

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 Opening: 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 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. Notice: If you are a Current Employee, please log into myURHR to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward. Learn. Discover. Heal. Create. 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.

Responsibilities

Manages and oversees all phases of human subject research, including study design, budgeting, and regulatory compliance. Responsible for mentoring research coordinators and ensuring adherence to Good Clinical Practices (GCP) and institutional policies.