Clinical Trials Associate (CTA)

South San Francisco, CA 94080

Posted: 10/09/2018 Industry: Other Area(s) Job Number: 31883

Clinical Trials Associate (CTA) The CTA will support the clinical operations study team. Acts as a central contact for the clinical team for designated project communications, correspondence and associated documentation. Perform administrative tasks to support team members with clinical trial execution as needed. • Helps ensure clinical studies and sites adhere to protocol, GCP and company SOPs • Maintains multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample tracking • Assists in the structure development of the TMF and filing system • Responsible for filing and maintaining up to date study documents • Prepares, packages, and sends documents and materials to clinical trial sites and vendors as needed • Tracks and coordinates CRO and third-party vendor activities • May receive and review all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference, and maintains documentation as required • Assists with ensuring that regulatory documents are updated in a timely and appropriate manner • Assists with the development of site tools and clinical trial start up activities • Secures, with guidance from study lead, clinical trial insurance to support study start up • Coordinates Contracts Approval Process, including obtaining appropriate approvals and signatures for all clinical Agreements in accordance with corporate policies to ensure compliance and standardization of process • Prepares, requests, and tracks Purchase Orders for contracted services across the clinical study(ies). • Reviews subject visit schedules, site budgets, and clinical database to approve site payments • Confirms the accuracy of administrative data • Provides general support to the Clinical Operations team • Performs other related duties and tasks, as required • Assists with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings • Ensures compliance with policies, SOP’ s and associated documents as well as industry regulations
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