Human Sub Research Spec 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):

220 Hutchison Rd, Rochester, New York, United States of America, 14620

Opening:

Worker Subtype:

Regular

Time Type:

Part time

Scheduled Weekly Hours:

20

Department:

400058 Medicine M&D-Nephrology Div

Work Shift:

Range:

UR URG 108

Compensation Range:

$51,810.00 - $72,534.00

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:

Coordinates human subject research activities, which may include multiple site human subject studies. May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. Develops, implements and evaluates recruitment strategies, information, data systems and study management systems. Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents.

Responsibilities GENERAL PURPOSE: The Department of Medicine, Division of Nephrology, at The University of Rochester is seeking a part-time (20 hours/week) Human Subject Research Specialist, Level II, to coordinate human subject research activities. The division of Nephrology has a robust research portfolio that encompasses basic, translational, and clinical research. This individual would support Clinical Trials under the direction of Dr. Fahad Saeed primarily focused on Improving Kidney Therapy-Decision Making for Older People with Kidney Disease. With minimum direction and latitude for independent judgement, this individual will be responsible for human subject research activities, including the development, implementation and evaluation of recruitment strategies, information, data systems and study management systems; development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents. This position may direct activities of subordinate staff and train research coordinators and other staff on activities associated with conducting human subject research specific to study protocols. Excellent interpersonal skills and interest in palliative care is desirable. JOB DUTIES AND RESPONSIBILITIES: Oversees and coordinates human subject research activities for multiple clinical trials, with an emphasis on those that are focused on Palliative Care Intervention to Improve Kidney Therapy-Decision Making for Older People with Advanced CKD - Participates in the planning, development and implementation of study design, budgets, protocols, consent forms, processes and policies - Receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials to immediate team members and relevant others - Develops, implements and evaluates recruitment strategies, information and data systems and study management systems for assigned studies - Facilitates eligibility screening and study recruitment activities, including study timelines and schedules appointments and study visits - Conducts study visits, schedules study appointments, does qualitative interviews to ensure research participant adherence with protocol requirements. Data Collection, Management and Maintenance - Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents - Performs data collection and uses required data systems for tracking study progression, monitoring and reporting on deliverables, quality, and safety tracking, according to protocol requirements and established operational procedures and timelines - Maintains relevant study logs, through sponsors related, and University related systems, including OnCore, according to UR and department Standard Operating Procedures (SOPs). Regulatory, Quality and Compliance - Participate with the IRB to address any issues with the on-going studies, prepare and submit annual reviews, prepare and submit study amendments. - Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. - Reviews study pr