Human Subject Research Coordinator II

University of Rochester•Rochester, NY

1d•Onsite

About The Position

The Epilepsy Human Subject Research Coordinator II provides research support and study coordination for studies in the Epilepsy Division of the Department of Neurology. The portfolio includes investigator-initiated research and pharmaceutical-company-funded multicenter clinical research studies involving children and adults. The coordinator exercises considerable independent judgment in coordinating assigned human-subject research studies, supports Principal Investigators, and assists faculty and residents or fellows with IRB submissions. The role coordinates study activities throughout their lifecycle, including participant prescreening, recruitment, consent, scheduling and conducting visits, data collection, assessments, and post-visit tasks. It also supports study start-up, protocol and consent development, feasibility and budget planning, database and source-document management, regulatory submissions, and communication among study teams, sites, sponsors, and the IRB. The coordinator ensures study activities and data meet protocol, institutional, and regulatory requirements and keeps current with applicable policies, Good Clinical Practice, industry standards, and therapeutic-area developments.

Requirements

Bachelor's degree and 2 years of experience in human-subject research coordination, or an equivalent combination of education and experience.
Word-processing and data-analysis software experience.
Ability to learn and work with multiple study protocols and requirements.
If applicable, department-specific experience is required.

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 and learning study protocols and requirements.
Recruit participants, schedule visits, and conduct study visits in accordance with study protocols.
Perform participant consent, data collection, and protocol-required assessments.
Address questions and concerns from study subjects or sponsors, escalating to the Principal Investigator as appropriate.
Coordinate study-visit tasks, including participant assessments, medication-compliance checks, vital signs, ECGs, and tasks assigned to nursing staff and the Principal Investigator.
Complete post-visit tasks, including specimen shipping, logging information in OnCore and Advarra Payment systems, and entering data into electronic data capture systems.
Develop and monitor calendars for participant visits throughout each study.
Maintain subject binders and ensure study documentation is complete and supports study integrity.
Manage study start-up activities, including obtaining quotes from ancillary departments and modifying consent forms to meet University of Rochester guidelines for RSRB/IRB submission.
Participate in planning, developing, and implementing study designs, protocols, consent forms, processes, and policies.
Work with Research Administration on time studies and budget feasibility, including the procedures, complexity, and effort required for studies.
Develop or manage study databases and source documents/case report forms, ensuring alignment with protocol requirements; complete timely data entry and review databases for incomplete items or queries.
Serve as liaison among cross-functional research teams, additional research sites, sponsors, and the IRB to facilitate communication and resolve issues.
Represent URMC and the Principal Investigator at study meetings as needed.
Prepare and maintain regulatory and study documentation for assigned studies.
Manage and submit IRB amendments and continuing reviews for approval.
Maintain essential documents for faculty and study personnel, including CVs, licenses, and training records.
Ensure compliance with applicable regulatory and institutional requirements and standards, and protect the integrity and security of study data.
Initiate, monitor, and ensure standardized protocol activities across study sites; implement appropriate corrective action when inconsistencies are identified.
Keep current with federal, state, sponsor, and institutional policies and laws, standard operating procedures, guidelines, Good Clinical Practice, industry standards, best practices, and relevant therapeutic-area trends; implement and monitor resulting study changes.
Perform other duties as assigned.