Experienced Clinical Research Associate, Site Management Poland

Job description

Opportunity in a dynamic multi‑sponsor environment - we are looking for experienced CRAs for our Site Management Team in Poland! Responsibilities: - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines - Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability - Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate - Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase - Ensure copies/originals (as required) site documents are available f...