Human Subjects Research Coordinator II

Responsibilities

• Manages projects primarily in Facioscapulohumeral Muscular Dystrophy, with the ability to work on projects in other neuromuscular diseases.
• Recruits, consents, enrolls, and retains study subjects across the NMD portfolio of human subjects' studies.
• Develops, implements, and evaluates subject recruitment and retention strategies.
• 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.
• 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 works 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.
• Assists in chart abstraction for the maintenance of patient databases.
• Demonstrates accountability for continuous learning related to clinical research.

Qualifications

• Bachelor's degree and 2 years of experience in human subject research coordination required.
• Or equivalent combination of education and experience.
• If applicable, department specific experience required.
• Experience as a Phlebotomist preferred.
• Experience as Human Subject Research Coordinator I preferred.
• Experience with Excel spreadsheets and electronic databases preferred.