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Represent CLIENT'SPI with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, Clinical Development & Medical Affairs (CDMA), Regulatory Affairs, other departments in Medicine, if required.
· Maintain expertise of currently assigned CLIENT'S SOPs, CLIENT'S WIs and where applicable; departmental practices, and systems.
· Maintain current knowledge of ICH, GCPs, and applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets. PhRMA code, and industry standards for the monitoring of Investigator Initiated Studies (IIS) at no cost to CLIENT'S.
· Provide documentation, including but not limited to invoices, time recording, and schedule of time off at the direction of CLIENT'S.
· Invoices should be submitted monthly as directed by CLIENT'S. The invoices may not be processed until all work products for that period have been received. Scope of Work Work as a member of the CDMA team supporting the Scientific Communications team. This role is responsible for end-to-end site management activities.
This includes but is not limited to:
· Serve as first line of contact for site staff in trial related questions pertaining to planning, conduct and closure of assigned IIS trials and sites.
· Maintain oversight of all site start-up and conduct-related activities (e.g. contracts, Essential Documents (e.g. RegDocs), training, Informed Consent Form updates, IMP resupply, drug supply requests, CTQA form processing, QAA documentation processing, document filing is CLIENT'S systems, etc.).
· Responsible for site logistics including review, distribution and tracking of site related documents & materials (e.g. ICFs, protocols, supplies).
· Update and maintain trial-specific system/databases/tracker (e.g. Vision Tracker, CTMS, etc.).
· Responsible for project compliance according to project plans and related tools.
· In close partnership with other stakeholders (e.g. Manager) maintain quality and operational oversight for assigned sites and escalate issues to the ERAD.
· In close partnership with other stakeholders (e.g. ERADs) take appropriate actions and make recommendations to the ERAD for improving site performance and/or quality. · Identify risks and propose and implement mitigation strategies.
· Closely track site recruitment and patient retention and enter updates in CTMS.
· Actively participate in trial and MSL team meetings including the creation and distribution of meeting minutes.
· Create trial specific slide decks, training material, etc. in accordance with CLIENT'S requirements.
· Enters country level information in CLIENT'S CTMS and related systems.
· Update trial budget, systems, project plans and tracker.
· Work with local colleagues to ensure start-up is achieved according to local timelines/goals
· Maintain oversight of key trial deliverables, take appropriate action and make recommendations to the ERAD (e.g. site initiation, patient recruitment, data cleaning, DBL)
· Follow up on audit/inspection findings and actively support implementation of CAPA.
· Maintain accurate local budget and collaborate with SciComm Ops and Controlling to be aligned with Client'snding trial budgets
· Support site & sponsor inspection readiness preparation, represent the trial (OPU level) during inspections if appropriate
· Oversee close out activities (collection of final report)
· Assist with oversight of all site start-up and conduct-related activities (e.g. contracts, Essential Documents (e.g. RegDocs), training, Informed Consent Form updates, IMP resupply).
· Maintain oversight of data quality and integrity through review of systems and trackers (e.g. BRAVE, lab portals, Clinergize).
· Other work may be assigned based on the shifting volume of studies, related activities and output of process improvement initiatives.
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