Job Overview Perform 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 Essential Functions Perform site monitoring visits selection initiation monitoring and close-out visits in accordance with contracted scope of work and regulatory requirements i e Valuable 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 for filing in the Trial Master File TMF and verify that the Investigator s Site File ISF is maintained in accordance with GCP and local regulatory requirements Create 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 Collaborate and liaise with study team members for project execution support as appropriate If applicable may be accountable for supporting development of project subject recruitment plan on a per site basis If applicable may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to l

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