Human Subject Research Specialist I

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

Full-time, 40 scheduled weekly hours

Compensation range: $21.78 - $30.53 per hour

Responsibilities

• Human Subject Recruitment, Screening, and Study Visits
  • Coordinates participant recruitment, screening, enrollment, and retention activities for assigned clinical research studies under supervision.
  • Reviews approved recruitment sources, medical records, and study databases to identify potential participants meeting 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.
• 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.
• 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 guidance, 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.
  • 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.
  • 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 continued development of clinical research knowledge and competencies.
• Performs other duties as assigned.

Requirements

• Bachelor’s degree required, or Associate’s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program, or equivalent combination of education and experience.
• Prior experience as a Phlebotomist preferred.
• Proficiency in word processing and data analysis software preferred.