Clinical Research Associate 1

Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, and inspection of study files. Participate in the evaluation of potential clinical sites, assist in design and preparation of protocols and case report forms, and generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Procure budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies by performing initiation site visits, arranging for shipment of clinical supplies, case report forms, and other necessary materials. Prepare site visit reports with identification of key accomplishments, key issues for resolution, and recommendations for follow-up actions. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files.