Human Subject Research Coordinator II

University of Rochester•Rochester, NY

2d•$25 - $35•Onsite

About The Position

The Epilepsy Human Subject Research Coordinator II provides research support and study coordination for investigator-initiated and pharmaceutical company-funded multicenter clinical research studies involving children and adults in the Epilepsy Division of the Department of Neurology. The coordinator exercises considerable independent judgment and coordinates assigned human-subject research studies, supporting Principal Investigators and the research team, including faculty, residents, and fellows with IRB submissions. The role oversees participant recruitment, screening, scheduling, study visits, consent, data collection, assessments, and follow-up tasks. It coordinates clinical and protocol procedures, maintains study calendars, binders, databases, source documents, case report forms, and regulatory records, and completes timely data entry. The coordinator also supports study start-up and design, prepares and submits IRB materials, works with research administration on feasibility and budgets, and serves as a liaison among the research team, study sites, sponsors, and IRB. The coordinator ensures study conduct and data meet applicable regulatory, institutional, and protocol requirements, maintains the integrity and security of study data, monitors consistency across sites, and implements corrective actions when needed. The position requires keeping current with relevant policies, laws, Good Clinical Practice, industry standards, and therapeutic-area developments.

Requirements

Bachelor's degree and two years of experience in human-subject research coordination, or an equivalent combination of education and experience.
Word-processing and data-analysis software skills.
Ability to learn and coordinate multiple study protocols and exercise independent judgment.
Ability to recruit and coordinate participants, conduct study visits, and complete protocol-required activities.
Ability to maintain accurate study, regulatory, and data records and ensure compliance with applicable requirements.

Nice To Haves

Experience as a Phlebotomist.
Experience as a Human Subject Research Coordinator I.
Experience with eRecord.
Experience using iMedidata Rave, Zelta, and other electronic data capture systems.
Knowledge of REDCap.
SOCRA Certification in Clinical Research upon hire.
Association of Clinical Research Professionals (ACRP) certification upon hire.

Responsibilities

Oversee and coordinate human-subject research activities, including prescreening potential participants across multiple studies.
Learn study protocols and recruit participants, schedule visits, obtain consent, collect data, and conduct protocol-required assessments.
Address questions and concerns from participants or sponsors, escalating issues to the Principal Investigator as appropriate.
Coordinate study visits and related tasks, including participant assessments, medication-compliance checks, vital signs, ECGs, and tasks assigned to nursing staff or the Principal Investigator.
Complete post-visit activities, including specimen shipping, logging information in OnCore and Advarra Payment systems, and entering data in electronic data capture systems.
Develop and monitor participant visit calendars and maintain complete subject binders.
Manage study start-up, obtain quotes from ancillary departments, and modify consent forms according to University guidelines for IRB submission.
Participate in planning and implementing study designs, protocols, consent forms, processes, and policies.
Work with Research Administration on time studies, budget feasibility, study procedures, and estimates of study complexity and effort.
Develop or manage research databases, source documents, and case report forms aligned with protocol requirements; enter data promptly and review databases for missing items or queries.
Coordinate communication among the research team, other research sites, study sponsors, and IRB; represent URMC and the Principal Investigator at study meetings as needed.
Prepare and maintain regulatory and study documentation, and manage IRB amendments and continuing reviews.
Maintain essential documents for faculty and study personnel, including CVs, licenses, and training records.
Ensure compliance with regulatory and institutional requirements, protect study-data integrity and security, and standardize protocol activities across study sites.
Identify inconsistencies in study activities and implement immediate, appropriate corrective actions.
Remain current on applicable policies, laws, standard operating procedures, Good Clinical Practice, industry standards, best practices, and relevant therapeutic-area trends; implement and monitor resulting study changes.
Perform other duties as assigned.