Human Subject Research Specialist II

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.

Job Location (Full Address):

265 Crittenden Blvd, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Part time

Scheduled Weekly Hours:

20

Department:

400110 Public Health Sciences

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108 H

Compensation Range:

$25.14 - $35.24

Responsibilities:

Coordinates human subject research activities for the Preventive Cardiology Research Program. Under general direction of the Principal Investigator, coordinates day-to-day study activities, supports participant recruitment and enrollment, maintains study documentation, and helps ensure compliance with federal, sponsor, and University requirements. Participates in study planning, data collection, regulatory activities, and study management while collaborating with investigators, study staff, and participants.

ESSENTIAL FUNCTIONS

• Study Recruitment: Coordinates human subject research activities for one or more studies. Assists with participant recruitment, screening, consent, scheduling, data collection, and maintenance of study records. Participates in development of study documents, protocols, consent forms, CRFs, and study procedures.
• Study Coordination and Communication: Serves as the primary day-to-day contact for participants, investigators, study staff, and sponsors. Coordinates study visits, maintains communication with the PI and research team, and ensures protocol activities are completed accurately and on time.
• Study Management: Maintains study databases, tracking systems, documentation, and reports. Reviews study progress, monitors timelines, assists with study finances and participant payments, and supports quality assurance activities.
• Regulatory & Protocol Compliance: Maintains regulatory documentation and assists with IRB submissions, amendments, continuing reviews, and study closeout. Ensures adherence to protocol requirements, Good Clinical Practice (GCP), and institutional policies.
• Training & Operational Support: Provides protocol-specific training and guidance to research staff as appropriate. Assists with implementation of study procedures and supports consistent practices across study activities.
• Financial & Administrative Support: Coordinates financial tracking, budget documentation, and study-related purchasing in accordance with institutional requirements.
• Professional Development & Compliance: Maintains knowledge of federal, state, sponsor, and institutional regulations and completes required training. Keeps current with GCP guidance and research best practices.
• Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 2 years of experience in human subject research coordination required
• Or equivalent combination of education and experience
• If applicable, department specific experience required
• Experience as a Phlebotomist preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Word processing and data analysis software required

LICENSES AND CERTIFICATIONS

• SOCRA - Certification In Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred

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