Clinical Research Associate II

Conduct ongoing study monitoring through frequent periodic site visits, protocol adherence checks, and inspection of study files. Generate clinical SOPs, policies, and plans while participating in protocol design, case report form preparation, and site evaluation. Manage procurement of budgets, contracts, and regulatory documents, then initiate studies by arranging site visits and shipment of clinical supplies. Prepare site visit reports detailing key accomplishments, issues, and follow-up actions, and conduct termination visits to obtain final investigator reports. Maintain clinical archives and electronic files under the direction of the clinical study team. Requires a BA, BS, RN, or BSN with one to two years of clinical research experience and adherence to GCPs.