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University of Rochester Human Subject Res Coord II - 219036 in Rochester, New York

Human Subject Res Coord II

Job ID

219036

Location

School of Medicine & Dentistry

Full/Part Time

Full-Time

Favorite Job

Regular/Temporary

Regular

Opening

Full Time 40 hours Grade 053 Neurology MIND/NPA

Schedule

8 AM-4:30 PM

Responsibilities

Position Summary:

With considerable latitude for independent judgment, coordinates all aspects of assigned human subject research studies for the department of Neurology Movement Disorders division. Typically responsible for the successful coordination of complex interventional or large multi-site studies. Provides assistance to the Principal Investigator and works as an integral part of the research team. Mentors Human Subject Research Coordinator I.

Responsibilities:

Study Visits:

Recruits, consents, schedules, and conducts research subject visits for complex studies (i.e., industry-sponsored clinical drug trials involving greater risk to subjects) in accordance with study protocol, coordinating these visits with the Principal Investigator.

  • Develops, implements, and evaluates subject recruitment and retention strategies.

  • Consents subjects to assigned research studies.

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

  • Draws blood and performs testing such as ECG, timed mobility tests, and cognitive function tests, depending on the protocol.

  • Coordinates and documents dispensing and returning of study drugs/materials.

  • Resolves questions and concerns received from study subjects, triaging to Principle Investigator as necessary.

  • Develops, implements, and monitors systems and methods to ensure quality, safety, efficiency, and consistency in the processing of human subject research data.

  • Reviews study progress, including coordinating and monitoring financial data for budget and variance reporting, documentation, and reporting deliverables.

  • 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.

Mentoring:

Mentors and trains Human Subject Research Coordinator I (HSRC I) on activities related to conducting human subject research.

  • Provides study-specific training, oversight, and back-up support.

  • Trains on federal, state, sponsor, and/or institutional regulations, policies, and practices related to human subject research.

  • Mentors on activities specific to conducting research for complex studies.

  • Completes annual performance evaluations/reviews for HSRC I.

Regulatory Oversight:

Oversees and manages the regulatory details for multiple assigned research studies.

  • Creates, modifies, organizes, and maintains study documentation for the regulatory file.

  • Manages and submits study applications, amendments, and continuing reviews for IRB approval.

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

  • Ensures the integrity and security of all study documents at all times.

  • Initiates, monitors, and ensures that regulatory activities are standardized across studies. Implements immediate and appropriate corrective action when inconsistency of activities is identified.

Liaison:

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.

  • Troubleshoots and 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.

Data Management:

Develops and/or manages databases (e.g., EDC) for research studies.

  • Develops, implements, and monitors systems and methods to ensure data integrity.

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

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

  • Exports research data used for analysis and preparation of presentations, abstracts, and publications.

Continuing Education:

Demonstrates accountability for continuous learning related to clinical research.

  • Keeps current with study-specific training, including understanding specific details of study protocol, all relevant sponsor and institutional policies, standard operating procedures, and guidelines.

  • Attends training sessions and other educational opportunities related to clinical research in order to 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 three years of experience in human subject research coordination; or an equivalent combination of education and experience.

Preferred Qualifications

  • Experience as a Human Subject Research Coordinator I and professional research coordinator certification (e.g., SoCRA or ACRP) highly preferred.

  • Phlebotomy training highly preferred.

  • 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.

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