Human Subject Research Specialist II

University of Rochester•City of Rochester, NY

1d•$25 - $35

About The Position

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. 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.

Requirements

Bachelor’s degree required
2 years of experience in human subject research coordination or equivalent combination of education and experience required
Word processing and data analysis software required

Nice To Haves

Experience as a Phlebotomist preferred
Experience with pediatric population; much preferred
SOCRA – Certification in Clinical Research preferred
Association of Clinical Research Professionals (ACRP) preferred

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
Oversees and coordinates human subject research activities for single or multiple sites.
Participates in the planning, development, and implementation of study design, budgets, protocols, consent forms, processes, and policies, including multiple therapeutic areas.
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.