Clinical Research Specialist

Job description

Job Summary With principal investigator oversight, prepares, evaluates and implements research studies to enhance the advancement of clinical practice. Essential Functions: - May serve as primary coordinator / project manager on a variety of research studies with low or moderate regulatory, clinical, and operational complexity; supports the PI and research team members. - Evaluates and prepares research studies for implementation including: assessment of operational feasibility; budget development; preparation of IRB documents; institutes protocol operations (generation of data collection tools, case report forms); attends study meetings. - Identifies, recruits, screens, and enrolls eligible subjects per protocol; with appropriate training and delegation, performs protocol-required research activities and/or protocol-required research procedures with low clinical complexity (e.g. six-minute walk test, SF-36, etc.). - With appropriate training and delegation, monitors patient status; collects, reviews, and documents data into a variety of systems per protocol. - Maintains research studies in compliance with federal, state, and local law, GCP, contracts, and institutional policies. -...