Sr Human Subject Research Specialist

Under general direction and with considerable latitude to exercise independent judgement, serves as senior research specialist for the Neuromuscular Disease division. Manages and oversees the operations of assigned divisional clinical research programs. Manages and coordinates all aspects of complex multi-center and international studies and projects. This includes oversight of inventory, preparation, calibration and cleaning processes of remote research equipment, coordinating and tracking of equipment shipments, monitoring of equipment inventory and initiating and coordinating equipment purchases. Creates patient facing study materials e.g. manuals, and standard of operation manuals for study set up. Provides support to the Principal Investigator, Research Administration, and research study staff working as an integral part of the study team. Responsible for the coordination and oversight of regulatory compliance for assigned Neuromuscular Disease division research program. Plans, directs, monitors and coordinates all phases of human subject research, which may include multi-site, community-based research or multiple therapeutic areas. Manages, designs, implements and evaluates study changes. Develops, manages, and coordinates with sites outside the University of Rochester with the Empire State ALS Alliance. Directs the planning, implementation, coordination, operation and evaluation of divisional procedures required to ensure quality study execution. Creates recruitment, retention and outreach planning for the Neuromuscular Disease division clinical research programs to grow and enhance clinical research operations.

Responsibilities

Serves as senior research specialist for the Neuromuscular Disease division; Manages and oversees the operations of assigned divisional clinical research programs; Manages and coordinates all aspects of complex multi-center and international studies and projects; Provides support to the Principal Investigator, Research Administration, and research study staff; Responsible for the coordination and oversight of regulatory compliance for assigned Neuromuscular Disease division research program; Plans, directs, monitors and coordinates all phases of human subject research; Creates recruitment, retention and outreach planning for clinical research programs

Requirements

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

Nice to have

Master’s in Health Science Related Field preferred; Experience as a Phlebotomist preferred; Experience in human subject research coordination for Neurologic Disorders preferred; SOCRA - Certification In Clinical Research upon hire preferred; Association of Clinical Research Professionals (ACRP) upon hire preferred