Human Subject Research Specialist II

The Study Coordinator will coordinate clinical research projects involving patients with muscular dystrophy, in specific, myotonic dystrophy. These projects include clinical trials evaluating genetic therapies targeting the root cause of the disease and observational studies, e.g., leveraging a remote research platform developed by the DM research team. The study coordinator will assist in enhancing and expanding the remote research platform. The Study Coordinator II will work as an integral part of the research team, assisting the principal investigator, communicating with study participants, and the broader DM community. This role mentors Human Subject Research Coordinator I(s) and supervises students as assigned.

Responsibilities

Coordinates, schedules, and conducts research study visits in accordance with the protocol; Assists in remote research platform management, including monitoring equipment and facilitating remote patient blood sample collection; Uses independent clinical judgement to recruit, consent, enroll, and retain study subjects; Ensures adherence to regulatory requirements and manages IRB submissions; Mentors and trains NMD Study Coordinators and provides back-up support; Develops and manages databases for research studies; Attends training sessions and participates in weekly study team meetings; Performs other duties as assigned

Requirements

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; Word processing and data analysis software required

Nice to have

Experience as a Phlebotomist; Experience as Human Subject Research Coordinator I; Expertise with REDCap; SOCRA - Certification In Clinical Research upon hire; Association of Clinical Research Professionals (ACRP) upon hire