Human Subject Research Specialist II

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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:

400626 Psychiatry M&D Research

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108

Compensation Range:

$52,300.00 - $73,300.00

Responsibilities:

The Human Subject Research Specialist II will serve as a senior member of a federally funded research program in Dr. Caroline Silva's lab at the University of Rochester Medical Center. The lab's work focuses on cultural-social factors in suicide risk and prevention among Hispanic/Latino adults, and this position will support an NIMHD-funded R01 (R01MD020523) examining daily social connection and well-being among English- and Spanish-speaking Hispanic/Latino adults using ecological momentary assessment (EMA). The HSRS II will oversee day-to-day study operations and research personnel while also assisting with participant recruitment, informed consent, assessments, suicide risk procedures, data management, and regulatory activities as needed. They will provide direct supervision for up to 2-3 other lab employees and students volunteering in the lab, orienting new members to study protocols, and coordinating study recruitment between RAs and students to maximize recruitment goals. The specialist will also support dissemination activities and participate in weekly lab meetings. This is a full-time position.

ESSENTIAL FUNCTIONS

Recruitment: Lead the development and implementation of recruitment strategies across clinical and community settings. Oversee and conduct eligibility screening using structured protocols, including review of referrals, medical records (when applicable), and brief screening interviews. Coordinate with outpatient clinics and community partners, monitor recruitment and retention metrics, and recommend adjustments to support enrollment goals.

Assessments: Oversee and conduct informed consent procedures in English and Spanish and administer baseline and follow-up assessments, including structured interviews and self-report measures. Train and monitor research staff in assessment procedures and protocol fidelity. Support participant onboarding for EMA, including smartphone-based survey setup and troubleshooting. Monitor participant safety, including conducting suicide risk assessments as needed and ensuring study procedures for documentation and escalation are followed. Maintain regular contact with participants to support retention.

Supervisory Duties: Directs the activities of staff members and student volunteers in the lab, supervising their collection, compiling and analysis of study data, including timely responses to protocol safety flags and outreach to/from study participants. Coordinate assignments and schedules, monitor completion and adherence to study procedures, and provide feedback and support. Trains new research staff members and student volunteers on the activities associated with conducting human subject research specific to study protocols and in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements. Lead or co-lead weekly study meetings, coordinate study workflows, and track progress toward recruitment, assessment, and other project milestones.

Data Management: Develop, implement, and monitor data management and quality assurance procedures using REDCap and related platforms. Oversee data entry and cleaning; monitor data quality, completeness, EMA compliance, and missing data; resolve discrepancies; and prepare routine study progress reports. Maintain accurate study records and ensure data are stored securely in accordance with protocol and institutional guidelines.

Regulatory: Lead and assist with preparation and submission of IRB protocols, amendments, and continuing reviews. Maintain regulatory documentation and study materials, including consent forms, standard operating procedures, and training records. Document protocol deviations and other reportable events, respond to IRB requests in a timely manner, and monitor study activities for compliance with approved procedures.

Dissemination: Conduct literature reviews and assist with preparation of manuscripts, abstracts, presentations, and grant materials. Support preparation and formatting of tables, figures, and references; organize project documentation for dissemination; and complete other study-related 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
• Professional Research Coordinator Certification (SoCRA or ACRP)

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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