Coordinate and track data to support the clinical research teams (CRTs) and departments. Responsibilities will include, but are not limited to, EMR data abstraction, EDC data capture, assisting with AE/SAE reporting and study queries. Ensures all activities are conducted according to Mission Health System SOPs and all applicable GCP and ICH regulations and guidelines.
Required Education: Associate's Degree, or in lieu of a degree, five years direct experience.
Preferred Education: Bachelor's Degree
Required License/Certification: Clinical Research Certification (see below) within 3 years of hire.
Preferred License/Certification: CCRP (Certified Clinical Research Professional), CCRA (Certified Clinical Research Associate), ACRP-CP or PM (ACRP Certified Professional or Project Manager), or CRA (Certified Research Administrator).
Required Experience: At least one (1) year of experience in clinical research. Must be able to present and communicate to various lines of business. Strong organizational skills and ability to work with minimal supervision. Data analysis experience. High computer literacy with ability to use clinical trial databases, electronic data capture, and MS Excel. Ability to learn new software. Understanding of clinical research processes. Knowledge of scientific, medical, and regulatory terminology, including GCP and GMP.
Preferred Experience: At least 2 years of experience providing data analysis in a business/healthcare setting. EMR data abstraction experience. EDC data capture experience.