University of Rochester

Private research university in Rochester, NY

Human Subject Research Specialist 1 Pediatric Allergy

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeRochester, NY, USA$21.78 - $30.53In-person

About the Job

Requirements

A bachelor's degree is required, or an associate's degree and completion of six months in the Human Subject Research Coordinator Trainee program, or an equivalent combination of education and experience.
Prior experience as a phlebotomist is preferred.
Word processing and data analysis software proficiency is preferred.
Experience as a phlebotomist or willingness to train is preferred.
CITI Good Clinical Practice and Human Subjects Protection certifications are preferred.
Dry ice shipping certification is preferred.

Responsibilities

Coordinate and support administrative and logistical details required to initiate and conduct pediatric allergy and immunology human subject research, including receiving, distributing, and explaining study information such as protocols and human subject recruitment materials to study subjects, immediate team members, and relevant others.
Coordinate and support sample kit preparation and distribution, and process biospecimens for pediatric allergy and immunology human subject research.
Assist with human subject recruitment and screening, including reviewing study site patient databases and office records for patients who meet protocol inclusion criteria. Participate in developing recruitment strategies for allergy patients and children or adults without allergies, conduct telephone interviews to screen potential study candidates, and review medical chart history with the Principal Investigator to verify atopy diagnoses.
Conduct study visits to ensure research participant adherence to protocol requirements, including medication use, biological sample collection, REDCap questionnaire completion, and other interventional activities. Document adverse events and report them to senior study staff, the Principal Investigator, the Institutional Review Board, the sponsor, or other required recipients. Ensure all data are collected and secured within approved parameters and procedures.
Work with the Rochester and central Institutional Review Boards, as appropriate, to initiate study protocols, modify study procedures, and produce continuing review information for assigned studies.
Act as liaison with the sponsor’s monitor by providing data clarifications, reviewing study protocols, ensuring thorough understanding and communication, responding to questions during the study, communicating and documenting adverse events as advised by the Principal Investigator, and ensuring regulatory and other documents, such as consent forms and case report forms, are complete, accurate, and available for review. Communicate with the sponsor to clarify data queries and determine report format. Prepare for, participate in, and serve as liaison for scheduled sponsor monitoring visits, including pre-study inspection, initiation, ongoing, and closeout visits.
Keep current with federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines; make recommendations; and demonstrate accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
Keep current with industry standards, best practices, and trends in therapeutic areas relevant to research studies, and recommend and implement changes as appropriate.
Perform other duties as assigned.

Desired Qualifications

Excellent organizational skills are preferred.

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:

Department:

400200 Ped Allergy/Immunology-SMD

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.78 - $30.53

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 the activities associated with human subject research in the department of pediatric allergy and immunology.

ESSENTIAL FUNCTIONS

Coordinates and supports the administrative and logistical details required to initiate and conduct pediatric allergy and immunology human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to study subjects, immediate team members, and relevant others.
Coordinates and supports sample kit preparation and distribution, and processing biospecimens, as part of pediatric allergy and immunology human subject research.
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 for allergy patients and children/adults without allergies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify atopy diagnoses.
Conducts study visits to ensure research participant adherence with protocol requirements, such as taking of medications, collection of biological samples, completion of REDCap questionnaires, and/or other interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities. Ensures that all data are collected and secured within approved parameters and procedures.
Works with the Rochester IRB (Click) and central IRB's, when appropriate, to initiate study protocols, modify study procedures, and produce continuing review information for any assigned studies.
Acts as liaison with Sponsor’s Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review. Communicates with Sponsor to clarify data queries to determine report format. 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).
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 in accordance with Good Clinical Practice standards and guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies. Makes recommendations and implements changes as appropriate.
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
Prior experience as a phlebotomist preferred

KNOWLEDGE, SKILLS AND ABILITIES

Word processing and data analysis software preferred
Excellent organizational skills preferred
Experience as a phlebotomist or willing to train preferred

LICENSES AND CERTIFICATIONS

CITI GCP and HSP preferred
Dry Ice Shipping 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.

About the Company

University of Rochester

Private research university in Rochester, NY

The University of Rochester is a research university with programs spanning the humanities, health care, business, education, music, engineering, and the sciences.

Company size: Not listed
Company stage: Not listed
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