Clinical Research Coordinator / Research Associate
Serving as Clinical Research Coordinator for clinical research trials being conducted by PNRI. • Working with the Principal Investigator and study staff in study-specific activities such as: o Screening patients given inclusion/exclusion criteria, informed consent of patients, scheduling study visits, assisting with dispensing of study medications, collect and process biological samples o Oversee study visits from start to finish; collect vitals, medical histories, and clinical information o Ensuring fidelity and reliability of study data entry into electronic CRFs and EDC formats, o Assisting with some study instruments such as MMSE and MOCA and other tasks as defined below.• Oversees all regulatory processes, including study startup, closeout, and ongoing IRB continuing reviews.• Establishing and maintaining a document management system for regulatory paper and electronic files. • Organizing and maintaining FDA, IRB and GCP required regulatory documentation for PNRI studies.• Attending internal site research meetings and effectively disseminating information regarding regulatory
