Human Subject Research Spec I

Human Subject Research Specialist I is an entry level clinical research coordinator responsible for coordinating the activities associated with human subject research. They will work under the supervision and guidance of the Principal Investigator (PI) and the research nurse coordinator for the particular study. This role will assume responsibility for less complex clinical research protocols, receiving guidance and instruction from senior level roles.

Responsibilities

Coordinates human subject screening activities, recruitment and subject visits; Reviews study site patient databases and office records for patients that meet protocol inclusion criteria; Screens potential study candidates; Conducts visits to ensure research participant adherence with protocol requirements; Enrolls appropriate patients in non-interventional, observational studies; Reviews and documents the dispensing and returning of study materials; Maintains OnCore database and study-specific research logs; Assists in entering research data into data collection forms and/or study databases; Coordinates administrative details required to initiate and conduct human subject research; Complies with Good Clinical Practice (GCP) and Federal Regulations; Participates in protocol-related training as required; Other duties as assigned

Requirements

Bachelor's degree required; Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required; equivalent combination of education and experience

Nice to have

Prior experience as a Phlebotomist; Word processing and data analysis software; Professional Research Coordinator certification (SoCRA or ACRP)