Human Subject Research Specialist I

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Job Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400129 Surgery Research

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.78 - $30.53

Responsibilities:

The Human Subject Research Specialist I is an entry-level clinical research coordinator responsible for supporting and coordinating activities related to human subject research studies within the Transplant Institute working with Surgery Research Infrastructure. Trial Principal Investigators will be faculty from Division of Nephrology, Medicine or Surgery. Working under the supervision of Assistant Professor, Surgery Research and with guidance from Principal Investigators (PIs), this position assists with the implementation and management of clinical research protocols, participant recruitment and retention, data collection, study documentation, and regulatory compliance activities. This role is assigned less complex research studies and receives ongoing training, instruction, and mentorship to develop proficiency in clinical research operations and human subject protections. The position serves as a key member of the clinical research team, helping to ensure studies are conducted in accordance with institutional policies, sponsor requirements, and applicable regulatory standards.

ESSENTIAL FUNCTIONS

Human Subject Recruitment, Screening, and Study Visits

• Coordinates participant recruitment, screening, enrollment, and retention activities for assigned clinical research studies under the supervision of senior research staff and the Principal Investigator (PI). Reviews approved recruitment sources, medical records, and study databases to identify potential participants who meet protocol eligibility criteria. Conducts participant outreach, schedules study visits, and assists with informed consent and other study-related activities in accordance with approved protocols and regulatory requirements. Supports participant adherence to study requirements and communicates questions, concerns, or potential issues to senior study staff and the PI as appropriate.

Protocol Implementation and Data Collection

• Assists with the implementation and day-to-day coordination of assigned clinical research studies. Conducts study visits and research procedures according to approved protocols, standard operating procedures, and departmental guidelines. Processes and ships study samples according to sponsor protocol. Collects, enters, maintains, and verifies study data and source documentation to ensure completeness, accuracy, confidentiality, and data integrity. Documents study activities, protocol deviations, and adverse events and reports findings to senior research staff and the PI in accordance with established procedures.

Study Documentation and Regulatory Compliance

• Maintains research participant records, regulatory files, study documentation, and other required research materials in accordance with sponsor, institutional, federal, and Good Clinical Practice (GCP) requirements. Assists with the preparation, collection, organization, and maintenance of study documents, including consent forms, case report forms, regulatory binders, and study correspondence. Ensures research records are complete, accurate, secure, and available for review by study teams, sponsors, and regulatory bodies. Once trained and under the guidance of the senior research staff, drafts regulatory documents for IRB review.

Study Coordination and Team Communication

• Coordinates administrative activities required to initiate and conduct human subject research studies. Communicates protocol requirements, study procedures, and research-related information to study team members as directed by senior research staff and the PI. Serves as a point of contact for routine participant and study-related inquiries. Assists with sponsor monitoring visits, study audits, protocol amendments, and resolution of data queries while ensuring study documentation remains current and complete. Maintains a QI folder in preparation for internal audits.

​Professional Development and Compliance

• Maintains required certifications and training related to human subject research, Good Clinical Practice, and institutional requirements such as adding studies and subjects to OnCore. Keeps current with applicable federal, state, sponsor, and institutional regulations, policies, procedures, and guidelines. Participates in ongoing professional development and study-specific training to support the continued development of clinical research knowledge and competencies.

Other Duties

• Performs other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree required or
• Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required
• Or equivalent combination of education and experience
• Prior experience as a Phlebotomist preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Word processing and data analysis software preferred

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