Human Subject Research Specialist 1

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):

265 Crittenden Blvd, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400981 Neuro-Ctr Health & Tech/CTCC

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.78 - $30.53

Responsibilities:

Coordinates the administrative activities associated with conducting multi-site, decentralized or other research studies. May assist Principal Investigator in conducting clinical studies, and in presenting study research results. Interacts with study sponsor and partners on research projects.

ESSENTIAL FUNCTIONS

• Coordinates the administrative activities necessary for clinical studies such as maintaining protocol and PI brochures for relevant study team members,  preparing materials for study visits, drafting and maintaining informed consent documents and the scope of work specific to projects and preparing study materials for study visits.  Under general direction from the Principal Investigator (PI), trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures,  study activities, source documentation and case report form (CRFs) completion, and adverse event reporting. Reviews and documents the dispensing and returning of study materials, such as study devices.  Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to. Develops independent research projects utilizing technology aimed at improving health globally.   
• Develops recruitment strategies and targets.  Recruits and consents participants for research studies.  Recruits and screens patients by reviewing study sites’ patient database and/or office records for potential study candidates that meet the proposed protocol criteria.   Conducts telephone screenings of patients in order to identify potential study candidates.
• Conducts remote and/or in-person assessments of research participants. Manages study visits to ensure patient compliance with protocol activities, and to ensure that all data is collected and secured within determined parameters and procedures.  Ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review.  Communicates adverse events to the PI,  documents them as advised and reports them to Institutional Review Board (IRB), Sponsor, and/or any other required recipients.   
• Disseminates research findings by drafting abstracts, presentations, and publications for peer review and industry forums.  Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines, and makes recommendations. Demonstrates accountability for continuous learning.  Keeps current with industry standards, best practices, trends in therapeutic areas relevant to research studies; makes recommendations and implements changes as appropriate. Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on-going and close out visits).  Follow Research Subject Review Board regulations and complete application paperwork, meet reporting requirements, and ensure compliance with institution and other regulatory agency requirements.
• Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

• Bachelor’s Degree required
• Equivalent combination of education and experience e.g. an Associate’s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required. 
• 1- 2 years’ experience in clinical research coordination or technology research or equivalent combination of education and experience preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of word processing and spreadsheets preferred.  
• Strong attention to detail and excellent interpersonal and communication skills.  

LICENSES AND CERTIFICATIONS

• CITI certification 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.