Human Subject Research Specialist II

Neuromuscular Disease Study Coordinator II

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.

Responsibilities include using independent clinical judgment to recruit, consent, enroll and retain study subjects across the NMD portfolio of human subjects' studies. The Study Coordinator II will develop, implement, and evaluate subject recruitment and retention strategies. They will manage and update registries used for subject recruitment, coordinate, schedule, and conduct research study visits according to the protocol, perform study-related procedures as outlined in the protocol, coordinate and document dispensing and returning of study drugs/materials, resolve study subject questions and concerns, ensure patient clinical care resources are available to support conduct of human subject studies in accordance with protocol, input/regularly update and review all patient information in the patient databases, mentor and train NMD Study Coordinators (HSRC I) on activities related to conducting human subject research, ensure compliance with all regulatory and institutional policies, serve as the liaison between cross-functional research team, additional research sites, research administration, study sponsors, and IRB, work with research administration team on pre-award and study start up documents, review study progress, represent the University and Principal Investigator at study meetings, develop and/or manage databases for research studies, ensure data is entered in a timely manner and database(s) is up-to-date, export research data or work with Data Office staff to obtain data for analysis and preparation of presentations, abstracts, and publications, demonstrate accountability for continuous learning related to clinical research, and participate in study team meetings and provide updates on project status and changes in regulatory requirements as needed.

Minimum education and experience required include a Bachelor's degree and 2 years of experience in human subject research coordination or equivalent combination of education and experience. If applicable, department specific experience is required. Experience as a Phlebotomist is preferred. Experience as Human Subject Research Coordinator I is preferred. Experience with Excel spreadsheets and electronic databases is preferred. SOCRA - Certification In Clinical Research upon hire is preferred.

Association of Clinical Research Professionals (ACRP) upon hire is preferred.