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Job Location (Full Address):

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

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400104 Neurology Movement Disorders

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 SUMMARY

Under the direct supervision of the Clinical Trial Manager with direction from the Principal Investigators, coordinates all aspects of assigned human subject research studies. Typically, responsible for the successful coordination of observational and clinical drug trials. Provides assistance to the other research coordinators and Principal Investigators, works as an integral part of the research team.

ESSENTIAL FUNCTIONS

Recruits, consents, schedules, and conducts research subject visits for _observational studies_ (i.e., less complex studies involving minimal risk to subjects) in accordance with study protocol, coordinating these visits with the Principal Investigator.

+ Recruits and consents subjects to assigned research studies.

+ Schedules and facilitates visits, performing study related procedures as outlined in protocol.

+ May perform testing such as cognitive function tests, depending on protocol.

+ Resolves questions and concerns received from study subjects, triaging to Principal Investigator as necessary.

+ Monitors study progress on a continuous basis.

+ Understands, implements, and provides training on most recent study protocol (e.g., amended protocol), procedures, documentation, and use of study materials to subjects and team members as appropriate.

+ Ensures compliance, following up and communicating as needed.

+ Manages the regulatory details for assigned research studies and registries.

+ Prepares and/or maintains regulatory and study documentation, including study protocols, consent forms, logs, certifications, labs, IRB and sponsor documents, and applicable communication.

Manages and submits amendments and continuing reviews for IRB approval.

+ Ensures compliance with all applicable regulatory and institutional requirements and standards.

Trains with and assists other Human Subject Research Coordinators as directed on complex studies (i.e., industry-sponsored clinical drug trials involving greater risk to subjects).

+ Receives training and mentoring on conducting human subject research from HSRC II.

+ Provides support with study visits, regulatory compliance, and queries.

+ Assists with specimen processing and shipping.

+ Serves as back-up research coordinator in the absence of the HSRC II.

Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolves issues, and enhance collaboration.

+ Maintains continuous communication with all relevant stakeholders.

+ Resolves issues in a timely manner.

+ Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol.

+ Represents the University and Principal Investigator at study meetings as needed.

Develops and/or manages databases for research studies and registries.

+ Ensures data is entered in a timely manner, accurate, and database(s) is up-to-date.

+ Responds to queries resulting from research visits in a timely manner, ensuring all issues are resolved.

Demonstrates accountability for initial and ongoing learning related to clinical research studies.

+ Keeps current with study-specific training, including understanding of inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and report completion, adverse event reporting, and all relevant sponsor and institutional policies.

+ Attends training sessions and other educational opportunities related to clinical research in order to learn and keep current with Good Clinical Practice guidelines, federal and state polices and laws, institutional certifications, industry standards and best practices, and trends in relevant therapeutic areas.

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

+ Or equivalent combination of education and experience required

KNOWLEDGE, SKILLS AND ABILITIES

+ Prior experience as a Phlebotomist

+ Word processing and data analysis software

+ Knowledge of word processing, spreadsheets, Red Cap and electronic data capture (EDC) software

+ Excellent communication skills, strong attention to detail, and strong interpersonal skills

+ Ability to work independently and as part of a team

CERTIFICATION

Association of Clinical Research Professionals (ACRP) upon hire 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.

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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.