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Primary Responsibilities:
? Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work, SOPs (and / or the Sponsor’s SOPs as appropriate) and the ICH GCP and associated regulations. May perform co-monitoring visits and other types of site visits as needed.
? Support development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan to meet project recruitment target.
? Administer protocol and related study training to assigned sites and establish regular lines of communication with sites, ensure that study milestones for sites responsible are met as planned with high quality (i.e., study startup, recruitment, database lock, closeout, etc.)
? Create and maintain appropriate documentation regarding site management, monitoring visit activities by submitting regular visit reports and/or other required study documentation.
? Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Take corrective action and preventative actions to mitigate the risk. Escalate quality issues as appropriate.
? Manage the daily progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, Ethics Committee documents submissions and approvals, study drug management, document filing, site payments, data query generation and resolution. May support start-up phase and additional site-self assessment requirements.
? Collaborate and liaise with study team members for other project execution support as appropriate.