Sr Human Subject Research Specialist

The NMD Sr. HSRS would manage and oversee the activities that establish, monitor and maintain human subject research, primarily in Facioscapulohumeral Muscular Dystrophy, with the ability to work on other 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. Will plan, direct, monitor and coordinate all phases of NMD FSH human subject research, which may include multi-site, community-based research or multiple therapeutic areas. Will manage, design, implement and evaluate study changes. May supervise others up to two employees.

Responsibilities

Manage and oversee activities that establish, monitor and maintain human subject research, primarily in Facioscapulohumeral Muscular Dystrophy; Work on other projects in other neuromuscular diseases; Plan, direct, monitor and coordinate all phases of NMD FSH human subject research; Manage, design, implement and evaluate study changes; Supervise others up to two employees; Oversee NMD FSH human subject research activities for single or multiple sites; Develop, implement, and evaluate study subject requirement strategies, information and data systems and study management systems; Create, plan, develop, implement, and manage study design, budgets, protocols, consent forms, processes and policies; Represent sites, NMD FSH providers, study team, patients, study participants and the University; Manage and mentor NMD research coordinators of various levels; Ensure quality, safety, efficiency, and consistency in the processing of data; Manage expenses, equipment, and study materials; Keep current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines

Requirements

Bachelor's degree and 5 years of experience in human subject coordination required; Or equivalent combination of education and experience; Word processing and data analysis software required

Nice to have

Experience as a Phlebotomist preferred; SOCRA - Certification In Clinical Research upon hire preferred; Association of Clinical Research Professionals (ACRP) upon hire preferred