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): 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 H

Compensation

Range: $24.91 - $34.87 The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. Responsibilities: GENERAL PURPOSE The Gansner Lab focuses on the study of different types of high-risk child and adolescent media use (e.g. engagement with suicide or drug-related online content), and as such, has multiple ongoing collaborations with different hospital departments and clinical services. This posting is for recruitment of an individual who will be able to work directly under the PI, overseeing multiple different lab-related activities. They will assist the PI in drafting and submitting new study IRB protocols and protocol amendments in the aforementioned areas of research, as well as have a significant role in monitoring, record-keeping and coordinating all phases of human subject research studies to ensure that studies are performed according to IRB protocols. They will provide direct supervision for up to two other lab employees, and up to 3-4 undergraduate students volunteering in the Gansner Lab, orienting new members to study protocols, and coordinating study recruitment between RAs and students to maximize recruitment goals. to m assist the PI in training and monitoring research activities performed by student volunteers who may be intermittently rotating through the Gansner lab. This position will play a significant role in data analyses, drafting and submitting peer-reviewed manuscripts and grant proposals, and when needed, will also be able to assist in recruitment of adolescent and young adult study subjects. Finally, this position will coordinate the administration of needs assessments and interdisciplinary meetings required for the creation and development of a new clinical service at URMC to assess and manage high-risk youth digital media use. ESSENTIAL FUNCTIONS Participant recruitment, enrollment, and retention:

• Oversees and human subject research activities for both longitudinal ecological momentary assessment and cross-sectional survey studies.
• Helps recruit and enrolls participants when needed.
• Spearheads IRB protocol submissions and amendments, overseeing research activities of RAs and student volunteers (see Supervisory duties below), and responsible for documenting all protocol deviations.
• Ensures that IRB amendments are submitted and IRB feedback responded to in a timely manner and that protocol continuing reviews are completed by required due dates.
• Keeps current with industry standards, best practices, and relevant to research studies and designs, implements and monitors resulting study changes.

Interdisciplinary Coordination for Clinical Service Development.

• The Gansner Lab is developing and launching a new clinical service at URMC to assess and manage problematic digital media use in children and adolescents.
• This service will operate at multiple levels, including direct patient consultations in acute care services, education and consultation to clinicians across different medical specialties and community outreach.
• This position will coordinate the multiple meetings with different heads of clinical service to discuss the role of this new service.
• They will oversee the conducting of various needs assessments within patient and provider populations to assess areas where the greatest support is needed, compiling and presenting these assessment results at coordination meetings.

Supervisory duties:

• 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.
• Directs the activities of student staff members rotating through the Gansner Lab, supervising their collection, compiling and analysis of study data, including timely responses to protocol safety flags and outreach to/from study participants.

Data Management:

• Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data.
• Reviews study progress, including data, documentation, and reporting deliverables.
• Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression.

Other duties as assigned. MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree Required
• Or equivalent combination of education and experience Required
• 2 years of experience in human subject research coordination Required

KNOWLEDGE, SKILLS AND ABILITIES

• Word processing and data analysis software required Required

LICENSES AND CERTIFICATIONS

• Professional Research Coordinator Certification (SoCRA or ACRP) Preferred

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