Human Sub Research Spec II

Job Location: 601 Elmwood Ave, Rochester, New York, United States, 14642

Full-time, 40 scheduled weekly hours (80% on-site, 20% remote)

Compensation Range: $25.14 - $35.24 per hour

Responsibilities

• Conduct study protocols as the primary coordinator, including study start-up activities such as WIRB and RSRB submissions, recruitment, enrollment, and entire conduct of given study under the direction of the Principal Investigator.
• Ensure compliance with all applicable regulatory and institutional requirements, Good Clinical Practice (GCP) guidelines, and sponsor requirements.
• Conduct visits to ensure research participant adherence with protocol requirements, including dispensing investigational medications and devices, performing procedures (e.g., obtaining lab specimens, electrocardiograms, collecting data during electrophysiology, diagnostic, interventional cardiology procedures, exercise testing, phlebotomy).
• Recruit, screen, consent, and enroll patients; perform record reviews and interviews.
• Review medical chart history with Principal Investigator (PI) to verify inclusion criteria before enrollment.
• Coordinate administrative details for initiating and conducting human subject research, such as IRB submissions and regulatory document collection.
• Distribute and explain study information, including protocols and recruitment materials, to team members.
• Ensure all team members understand and adhere to approved protocols, procedures, and documentation standards.
• Train staff on protocol details, including inclusion/exclusion criteria, informed consent, study activities, source documentation, case report form (CRF) completion, and adverse event reporting.
• Complete case report forms, create patient instructions and calendars, schedule appointments, and assist investigators as needed.
• Prepare for, participate in, and serve as a liaison for sponsor monitoring visits.
• Develop working relationships with sponsors, attend study meetings, and foster a positive research environment.
• Collect and report adverse and serious adverse events to sponsors.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree and 2 years of experience in human subject research coordination or equivalent combination of education and experience.
• Experience as a Phlebotomist preferred.
• Proficiency in word processing and data analysis software.
• Clinical skills in phlebotomy and EKGs preferred.
• SOCRA or ACRP certification in clinical research preferred upon hire.