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University of Rochester Human Subject Res Coord I - 217753 in Rochester, New York

Human Subject Res Coord I

Job ID

217753

Location

School of Medicine & Dentistry

Full/Part Time

Full-Time

Favorite Job

Regular/Temporary

Regular

Opening

Full Time 40 hours Grade 051 Neurology Movement Disorders

Schedule

8 AM-4:30 PM

Responsibilities

Position Summary:

Coordinates all aspects of assigned human subject research studies. Typically responsible for the successful coordination of observational studies. Provides assistance to the Senior Coordinators and Principal Investigator; works as an integral part of the research team.

Responsibilities:

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 Principle 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 Human Subject Research Coordinator II (HSRC II) 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 Principle 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.

Qualifications:

  • Bachelor’s degree and one year of experience in human subject research coordination; or an equivalent combination of education and experience.

  • Knowledge of word processing, spreadsheets, and electronic data capture (EDC) software preferred.

  • Must have excellent communication skills, strong attention to detail, and strong interpersonal skills.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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