Human Subject Res Coord II

Rochester, NY


Position Summary:

With considerable latitude for independent judgment, coordinates all aspects of assigned human subject research studies. Typically responsible for the successful coordination of complex interventional commercially-sponsored drug and device studies. Provides assistance to the Senior Coordinator and Principal Investigator as needed, and works as an integral part of the research team. Mentors Human Subject Research Coordinator I as appropriate.


Recruits, consents, and schedules research subject visits for complex studies (i.e., industry-sponsored clinical epilepsy drug trials) in accordance with study protocol, coordinating visits with the Principal Investigator as needed.

  • Works with multidisciplinary teams for the provision of additional resources needed to conduct study procedures (e.g., CRC, UR Imaging, URMC Labs, IDS, EEG technicians).

  • Uses databases and technology tools to identify and prescreen potential subjects for studies

  • Liaises with participants and ancillary personnel to ensure study visits components are in place and fully functional

Responsible for conducting study visits in accordance with research protocols including:

  • Conducts study visits to ensure subject compliance with medications; conduct ECGs, cognitive assessments and other protocol-specific tasks.

  • Coordinates and documents dispensing and returning of study drugs/materials.

  • Obtains blood and urine specimens as required by protocol and processes them on-site when needed; packages and ships specimens to central labs. Manages and ensures accurate source data in eDC (electronic data capture system). Clarifies and resolves data queries and determines the final report format.

  • Prepares for scheduled sponsor monitoring visits (i.e., pre-study inspection, initiation, on-going and close-out).

  • 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 coordinating and monitoring financial data for budget and variance reporting, documentation, and reporting deliverables.

  • Understands, implements, and provides training on most recent study protocol (e.g., amended protocol), procedures, documentation, and use of study materials to subjects and team members as appropriate. Ensures compliance, following up and communicating as needed.

Oversees and manages the regulatory details for multiple assigned research studies.

  • Creates, modifies, organizes, and maintains study documentation for the regulatory file which may include consent forms and case report forms.

  • Manages and submits study applications, amendments, and continuing reviews for IRB approval.

  • Ensures compliance with all applicable regulatory and institutional requirements and standards.

  • Ensures the integrity and security of all study documents at all times.

  • Initiates, monitors, and ensures that regulatory activities are standardized across studies. Implements immediate and appropriate corrective action when inconsistency of activities is identified.

Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolves issues, and enhance collaboration.

  • Maintains ongoing communication with all relevant stakeholders.

  • Troubleshoots and resolves issues in a timely manner.

  • Schedules, prepares for, and attends study sponsor meetings, virtual trainings; and CRO/Sponsor monitor visits. Represents the University and Principal Investigator at study meetings, as needed.

Manage databases for research studies.

  • Implements, and monitors systems and methods to ensure data integrity.

  • Ensures data is entered in a timely manner and database(s) is up-to-date.

  • Responds to queries resulting from research visits in a timely manner, ensuring all issues are resolved.

  • Exports research data used for analysis and preparation of presentations, abstracts, and publications.

Demonstrates accountability for continuous learning related to clinical research.

  • Keeps current with study-specific training, including understanding specific details of study protocol, all relevant sponsor and institutional policies, standard operating procedures, and guidelines and third-party vendor electronic systems.

  • Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and state polices and laws, institutional certifications, industry standards and best practices, and trends in relevant therapeutic areas.

Other duties as assigned.


  • Bachelor’s Degree preferred

  • And three years of experience in human subject research coordination; or an equivalent combination of education and experience required.

  • Proficiency with Microsoft Office Suite and electronic data capture (EDC) software preferred

  • Experience as a Human Subject Research Coordinator I and professional research coordinator certification (e.g., SoCRA or ACRP) preferred.

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion 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 status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 053 Neurology-Epilepsy Unit M&D
Schedule: 8:30 AM-5 PM; OCC WKENDS