Human Subject Research Specialist I

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:

400151 Urology M&D

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.36 - $29.90

Responsibilities:

This role coordinates the human subject research activities outlined in research protocols in the Department of Urology to advance translational and clinical research mission of the Department of Urology . This includes screening for eligible subjects according to protocol inclusion/exclusion criteria, consenting subjects, maintaining all documentation according to protocol, SOP & regulatory requirements and coordinating collection/processing of specimens, administration of research surveys and creating and updating research databases (REDCap or other platform as specified in the protocol) via collecting data, including compilation, registration and submission, from the EMR and other sources as applicable. The role will coordinate with PI, biobank, laboratory technicians and any other study team members and/or stakeholders to carry all out parameters of research activities as specified in the research protocol. This position plays a key role in ensuring research activities are conducted in compliance with institutional policies, IRB requirements, and study protocols.

ESSENTIAL FUNCTIONS

• Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing, and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others.
• Participates in human subject recruitment, screening and consenting activities, including reviewing applicable databases (like EMR) and office records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. May conduct consent process in person or via eConsent following all external and internal regulatory guidelines.
• Creates research database (Ex: REDCap) as specified in the study protocol. Meets with PI/other stakeholders to compile data dictionary. Inspects data from electronic records and other sources and enters this data into the electronic medium (Redcap, excel..etc) for each assigned study to the specifications of the data safety sheet and protocol. Meets with research team to understand/clarify any data parameter questions based on the data dictionary. Reviews all data collected for accuracy and completeness and determines if any actions are required to resolve any errors, omissions or discrepancies. Compiles reporting on status of data capture for research studies.
• Coordinates collection/processing of specimens, administration of surveys and other components of the research visit to ensure research participant adherence with protocol requirement. Coordinates with stakeholders like biobank, lab members, clinical staff etc. as applicable to meet study research goals for the Department of Urology.
• Maintains currently knowledge and practice of all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
• Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree required or Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required
• Skill in completing assignments accurately and with attention to detail required
• Understands and follows data integrity standards and processes required
Experience implementing and supporting data management systems in a scientific, research context (e.g. biospecimen software, electronic laboratory notebooks, , REDCap) preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Strong organizational skills required
• Excellent communication skills for describing progress and challenges to stakeholders required
• Attention to detail, patience, and a positive, customer-centric attitude required
• Demonstrated ability to develop proficiency with unfamiliar toolsets required
• Prior experience as a phlebotomist preferred

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.