Human Subject Research Specialist II

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:

400094 Neurology - NMD M & D

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108 H

Compensation Range:

$24.91 - $34.87

Responsibilities:

Coordinates and lead human subject research activities for the pediatric neuromuscular program, which may include start up for sponsored clinical trials and multiple site human subject studies. Develops, implements and evaluates recruitment strategies, information, data systems and study management systems. Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents. May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research

ESSENTIAL FUNCTIONS

• 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.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor’s degree required
• 2 years of experience in human subject research coordination or equivalent combination of education and experience required
• Experience as a Phlebotomist preferred
• Experience with pediatric population; much preferred

KNOWLEDGE, SKILLS AND ABILITIES

Word processing and data analysis software required

LICENSES AND CERTIFICATIONS

• SOCRA – Certification in Clinical Research preferred
• Association of Clinical Research Professionals (ACRP) 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.