Human Subject Research Coordinator 1 jobs in United States
cer-icon
Apply on Employer Site
company-logo

University of Rochester · 3 months ago

Human Subject Research Coordinator 1

The University of Rochester is defined by a deep commitment to Meliora - Ever Better. The Human Subject Research Coordinator 1 will coordinate all aspects of assigned human subject research studies involving Spanish-speaking patients, including recruitment, scheduling, and compliance with study protocols.

Health CareMedicalUniversities
check
H1B Sponsor Likelynote

Responsibilities

Recruits, consents, schedules, and conducts research subject visits for observational studies in accordance with study protocol, coordinating these visits with the Principal Investigator
Meets with Spanish-speaking patients interested in research after their clinical visit to discuss research opportunities
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
Assists Spanish-speaking patients with research visit appointment confirmation and transportation facilitation
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
Attends division and research meetings
Attends and leads talks with community groups such as the Ibero-American Action League
Participates in Ibero’s community advisory board
Partners with the Latino Health Coalition
Other duties as assigned

Qualification

Human Subject ResearchSpanish LanguageRegulatory ComplianceData Analysis SoftwarePhlebotomy ExperienceACRP CertificationCommunicationAttention to DetailInterpersonal SkillsTeamwork

Required

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

Preferred

Fluent in the Spanish language (verbal & written) Preferred
Prior experience as a Phlebotomist Preferred
Word processing and data analysis software Preferred
Knowledge of word processing, spreadsheets, Red Cap and electronic data capture (EDC) software Preferred
Excellent communication skills, strong attention to detail, and strong interpersonal skills Preferred
Ability to work independently and as part of a team Preferred
Association of Clinical Research Professionals (ACRP) upon hire Preferred

Company

University of Rochester

company-logo
The University of Rochester is a private research university located in Rochester, New York.

H1B Sponsorship

University of Rochester has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (234)
2024 (126)
2023 (130)
2022 (106)
2021 (100)
2020 (92)

Funding

Current Stage
Late Stage
Total Funding
$20.43M
Key Investors
National Science FoundationUnitedHealthcareSociety to Improve Diagnosis in Medicine
2023-09-25Grant· $18M
2023-07-26Grant· $0.07M
2022-09-20Grant· $0.05M

Leadership Team

leader-logo
David Linehan
Chief Executive Officer
linkedin
Company data provided by crunchbase