Two positions available. These positions perform clinical trial monitoring visits to assess compliance with study protocols, standard operating procedures (SOP's), Good Clinical Practice (GCP) and applicable regulatory requirements. Responsible for establishing trackers and maintaining regulatory documents, assisting in audit preparation and ensuring compliance at clinical sites. Close interactions with site investigators, research coordinators and field monitors. Ability to provide training to site research staff.
Clinical research study processes, study design and/or protocol management
Clinical trial monitoring procedures and clinical data reporting processes
GCP guidance and FDA regulations
Medical terminology and anatomy/physiology
Microsoft Suite of software products
Perform tasks requiring excellent attention to detail
Manage multiple deadlines and priorities while ensuring quality and timeliness
Work effectively and efficiently in a remote environment
Minnesota, Oregon, Nevada, Northern and Southern California
Education and/or Experience:
Bachelors degree in healthcare/science related field. However, upon evaluation, equivalent related experience and/or education may be substituted fro the degree requirement.
Minimum of three years (preferred) monitoring clinical research studies an/or protocol management according to GCP/FDA guidelines or verifying clinical data from medical records.
Good understanding of regulatory documents, monitoring, device accountability and adverse event reporting.
Clinical research certification is preferred ACRP or CRA certification.
About CORD LLC (Cumming Ophthalmic Research and Development)
CORD is a small startup ophthalmic company in Orange County, California conducting an FDA clinical study on a newly-designed intraocular lens.