Human Subject Research Spec I

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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:

40

Department:

400094 Neurology - NMD M & D

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.36 - $29.90

Responsibilities:

The Neuromuscular Disease Study Coordinator II will manage projects primarily in Facioscapulohumeral Muscular Dystrophy, with the ability to work on projects in other neuromuscular diseases. The research projects in the group include observational studies, clinical trials, and multi-center clinical research studies in both adult and pediatric subjects. The Study Coordinator II will have considerable latitude for independent judgment and will coordinate all aspects of assigned human subject research studies. This role provides assistance to the Principal Investigator(s) and works as an integral part of the research team. This role mentors Human Subject Research Coordinator I(s) and supervises students as assigned.

ESSENTIAL FUNCTIONS

• Uses independent clinical judgment to recruit, consent, enroll and retain study subjects across the NMD portfolio of human subjects’ studies. Develops, implements, and evaluates subject recruitment and retention strategies. Creates and modifies patient recruitment material as necessary. Manages and updates registries used for subject recruitment.
• Coordinates, schedules, and conducts research study visits according to the protocol to support successful achievement of milestones, specific aims, and study objectives. Performs study-related procedures as outlined in the protocol. Training will be provided to implement protocol’s procedures. Coordinates and documents dispensing and returning of study drugs/materials, as applicable. Resolves study subject questions and concerns, triaging to Principal Investigator, as necessary. Ensures patient clinical care resources are available to support conduct of human subject studies in accordance with protocol. Inputs/regularly updates and reviews all patient information in the patient databases to ensure the most accurate databases possible, including resolving data queries timely.
• Mentors and trains NMD Study Coordinators (HSRC I) on activities related to conducting human subject research and provides back-up support across the team as needed. Directs, 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. Keeps current with study-specific training, including understanding specific details of study protocol, all relevant sponsor and institutional policies, standard operating procedures, and guidelines. Troubleshoots and resolves operational issues related to studies.
• Develops, modifies and maintains regulatory requirements for multiple research studies. Manages IRB submissions to include study applications, amendments and continuing reviews. Creates, modifies, organizes, and maintains study documentation for the regulatory file. Ensures consistency and standardization of protocol activities across multiple sites. Responsible for monitoring compliance with all regulatory and institutional policies, and takes corrective action on issues identified. Trains on federal, state, sponsor, and/or institutional regulations, policies, and practices related to human subject research.
• Serves as the liaison between cross-functional research team, additional research sites, research administration, study sponsors, and IRB to facilitate communication, resolves issues, and enhance collaboration. Works with research administration team on pre-award and study start up documents providing expertise related to time studies and budget feasibility for study procedures, overall complexity and effort required for completing studies. Reviews study progress, including communicating with research administrator and updating OnCore or other workbooks on enrollment, visits, and other study procedures completed to ensure maximum payment is received and expenses are monitored in accordance with budget. Represents the University and Principal Investigator at study meetings, as needed. Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol.
• Develops and/or manages databases for research studies. Ensures data is entered in a timely manner and database(s) is up-to-date. Exports research data or work with Data Office staff to obtain data for analysis and preparation of presentations, abstracts, and publications. Develops, implements, and monitors systems and methods to ensure data integrity. Assist in chart abstraction for the maintenance of patient databases.
• Demonstrates accountability for continuous learning related to clinical research. 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. Participates in study team meetings and provides updates on project status and changes in regulatory requirements as needed.
• Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

• Bachelor’s degree required
• or equivalent combination of education and experience
• 2 years of experience in human subject research coordination required

KNOWLEDGE, SKILLS AND ABILITIES

• Department specific experience required, if applicable
• Word processing and data analysis software required
• Experience as a Phlebotomist preferred
• Experience as Human Subject Research Coordinator I preferred
• Experience with Excel spreadsheets and electronic databases preferred

LICENSES AND CERTIFICATIONS

• Professional Research Coordinator certification (SoCRA or ACRP) preferred

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