Clinical Mon Assoc I

Job description

About the job: Responsible for project activities associated with monitoring functions of Phase I through Phase IV clinical research studies and Real World Evidence (RWE) studies while developing an understanding of the drug development process, International Conference on Harmonization (ICH) / Good Clinical Practice (GCP) and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs). What You'll Do: - Perform in-house monitoring activity related to clinical trials while adhering to all applicable regulatory and SOPs - Perform on-site clinical trial monitoring, co-monitoring, and close-out activities, with oversight from project CRAs when required, while adhering to all applicable regulatory requirements and SOPs - May conduct independent on-site monitoring as sponsor requirements allow - Assist project teams with study start-up activities, including site selection and phone Pre-Study Visits to identify and evaluate potential investigative sites - Collect, review, file, and track regulatory documents for investigative sites, when required, including assisting the project CRA with...