Full Time/Permanent
Position Overview
The Clinical Research Associate helps design and conduct clinical studies of investigational medical and consumer devices. This includes recruiting and screening human subjects for clinical trials, obtaining informed consent from subjects, conducting patient contact portion of trials and preparing clinical data reviews and data summaries.
Essential Job Functions
· Recruits volunteers both within company and outside
· Manages participation of study subjects
· Instructs subjects on proper use of Blood Sugar Meters (BGM)
· Applies sensors and removes sensors from subjects (or monitors the subject’s self-application)
· Downloads data from sensors and makes sure it is stored in servers in correct format and location
· Arranges for and assists with the collection and review of clinical data
· Assists in the analysis of subject data
· Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines; assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy, and legibility
· Reviews data, prepares and presents clinical data reviews and data summaries
· Reviews clinical protocol, instructions for use, case report forms, informed consents, and other required documents for clinical studies
· Travels to sites where studies are performed (mostly in Boston area)
Experience
· 3-5 years of experience in nursing, clinical research or other patient-contacting work
Education / Certification
· Bachelor’s degree required
· Medical Technology MT (ASCP) or certification as a clinical research associate (CCRA) is desirable
Other Skills / Abilities
· Good oral and written communication skills, familiarity with Microsoft Excel and PowerPoint software, ability to travel (up to 20% US within assigned geographic territories and/or international), and participation in professional activities outside of normal business hours.
· Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates
· Early identification of unsatisfactory results, operations, or specific problems allows immediate action to be taken by appropriate groups
· Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project