h3Job Overview /h3pPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. /ph3Essential Functions /h3ulliPerform 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. /liliWork with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. /liliAdminister protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. /liliEvaluate 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.
/liliManage 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. /liliEnsure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. /liliCreate and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow‑up letters and other required study documentation. /liliCollaborate and liaise with study team members for project execution support as appropriate. /liliIf applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. /liliIf applicable, may be accountable for sit
📌 Clinical Research Associate, Site Management (Milano)
🏢 Iqvia
📍 Milano