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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:

400990 Clin & Trans Science Institute

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.36 - $29.90

_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:

Coordinates the activities associated with human subject research. Plans, directs, monitors and coordinates all phases of human subject research (which may include multi-site and community-based research, as well as multiple therapeutic areas and virtual telemedicine visits).

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.

+ Assists in human subject recruitment and screening activities, including reviewing study site patient databases 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. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.

+ Conducts visits to ensure research participant adherence with protocol requirements,such as taking of medications,properuse of device,and/or other interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or anyotherrequiredrecipients or entities.Ensuresalldata are collected and secured within approved parameters and procedures.

+ Ensures all immediate and extended team members understand and adhere to allaspects of allapprovedprotocols,procedures,andstandards for documentation and communication. Under general direction from the Principal Investigator (PI), trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures,study activities,sourcedocumentationandcasereportform(CRFs)completion, and adverse eventreporting.

+ Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.

+ Acts as liaison with Sponsor’s Monitor: to provide data clarifications, to reviewstudy protocols, to ensure thorough understanding and communication, to respond to questions that arise during the study, to communicate and document adverse events as advised by the Principal Investigator, and to ensure regulatory and other documents (such as consentforms and CRFs)arecomplete,accurateandavailableforreview. Communicates with Sponsor to clarify data queries to determine report format. Prepares for, participates in and serves as liaison forscheduled

+ Sponsor monitoring visits (i.e., pre-study inspection, initiation, on-going and close out visits).

+ Keepscurrentwithallfederal,state,sponsor and institutionalpolicies and laws, standard operating procedures and guidelines, and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to researchstudies; makes recommendations and implements changes as appropriate.

Other duties as assigned.

QUALIFICATIONS

+ Bachelor’s degree or Associate’s degree and completion of 6 months in Human Subject Research Coordination Trainee program required.

+ Or equivalent combination of education and experience required.

+ Prior experience as a Phlebotomist preferred.

+ Must have excellent interpersonal and communication skills required.

+ Must have strong attention to detail and organizational skills required.

+ Ability to work both independently and within a collaborative team environment required.

+ Knowledge of word processing and data analysis software 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 Classes). 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.

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Learn. Discover. Heal. Create.

Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries—always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.

If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals

At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better—Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.