Human Subject Research Coordinator II

The University of Rochester seeks an Epilepsy Human Subject Research Coordinator II to coordinate human-subject research studies in the Department of Neurology. The role supports investigators and research teams with study operations, participant visits, regulatory submissions, data management, and compliance.

Responsibilities

• Oversees and coordinates human subject research activities including pre-screening potential study participants for multiple research studies. Must be able to learn multiple study protocols to become well versed in study requirements. HSRC will recruit participants, schedule, and conduct subject visits for research studies in accordance with study protocol. Perform activities including but not limited to participant consent, data collection, and assessments as required per protocol. Resolves questions and concerns received from study subjects or sponsor, triaging to the Principal Investigator as necessary
• Conducts study visits; coordinating all tasks including participant assessments, medication compliance, clinical tasks (obtaining vital signs, ECG) as well as tasks assigned to nursing staff and Principal Investigator. Complete post-visit tasks, such as shipping specimens, logging in OnCore and Advarra Payment systems and data entry into the Electronic Data Capture (EDC). Develop and monitor visit calendar for all participant visits over the life of the study. Maintain subject binder, ensuring completeness for study integrity
• Manages study start up activities, including obtaining quotes from ancillary departments (imaging, laboratory, Clinical Research Center) and modifying consent forms per UR guidelines to ready for RSRB (UR’s IRB)/ Institutional Review Board (IRB) submission. Participates in the planning, development and implementation of study design, protocols, consent forms, processes and policies. Works with Research Administration team providing expertise related to time studies and budget feasibility for study procedures, overall complexity and effort required for completing studies
• Develops and/or manages databases and source documents/case report forms (CRF’s) for research studies, ensuring CRF’s are aligned with protocol requirements. Completes data entry in a timely manner and review database(s) for incomplete items or queries
• Serves as the liaison between cross-functional research team, additional research sites, study sponsors and IRB to facilitate communication and resolve issues. Represent URMC and Principal Investigator at study meetings as needed
• Prepares and maintains regulatory and study documentation for assigned research studies. Manages and submits amendments and continuing reviews for IRB approval
• Maintains essential documents for all Faculty and study personnel including CVs, licenses and training
• 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 that all protocol activities are standardized across study sites. Implements immediate and appropriate corrective action when inconsistency of activities is identified
• 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 Good Clinical Practice 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

Preferred

• Experience as a Phlebotomist preferred
• Experience as Human Subject Research Coordinator I preferred
• Experience with eRecord preferred
• Experience using iMedidata Rave, Zelta and other EDC preferred
• Knowledge of REDCap preferred
• SOCRA - Certification In Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred
• Phlebotomy experience
• Human subject research coordination
• eRecord
• iMedidata Rave
• Zelta
• Electronic data capture (EDC)
• REDCap
• SOCRA clinical research certification
• ACRP credential

Company

• Private research university offering bachelor's, master's, and doctoral degrees.
• Rochester, New York, USA
• https://www.rochester.edu/
• Founded in 1850
• 10001+ employees

Qualifications

• Bachelor's degree and 2 years of experience in human subject research coordination required
• Or equivalent combination of education and experience
• Word processing and data analysis software required
• Experience as a Phlebotomist preferred
• Experience as Human Subject Research Coordinator I preferred
• Experience with eRecord preferred
• Experience using iMedidata Rave, Zelta and other EDC preferred
• Knowledge of REDCap preferred
• SOCRA - Certification In Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred

Required skills

• Association of Clinical Research Professionals (ACRP) Certification, ERecord, Human Subject Research Coordination, IMedidata Rave, Phlebotomy, REDCap, SOCRA Certification in Clinical Research, Zelta

Preferred skills

• (106), (126), (130), (233), *2026, 2022, 2023, 2024, 2025, 3.9, 48, Accounting and Finance, Creatives and Design, Customer Service and Support, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Education and Training, Engineering and Development, Experience as Human Subject Research Coordinator I preferred, Experience as a Phlebotomist preferred, Experience with eRecord preferred, Glassdoor, H1B Sponsorship, Human Resources, Knowledge of REDCap preferred, Management and Executive, Represents job field similar to this job, Rochester, New York, USA, Trends of Total Sponsorships, https://www.rochester.edu/

Experience

• 2+ years