Preston Ferguson

Site Activation Specialist @Worldwide Clinical Trials

Track study-specific site regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the SAR Lead • Support the development and adaptation of country/site specific informed consent forms • Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities • Interface with relevant functional leads to ensure appropriate prioritization of essential document collection and review to facilitate synchronized start-up • Collect, receive, and perform first review of required study-specific site regulatory/essential in accordance with applicable SOPs, guidelines and relevant study specific plans. Implement corrective action as needed, prior to essential document review sign off and follow up on Non-Hold items post sign off (where applicable) • Where applicable, provide local follow up and updates of status of local EC submissions to the Regulatory Affairs and relevant teams assigned to the project • Where required, complete, manage and/or support country and site-specific activities (e.g, compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate • May perform pre-award feasibility studies • Support Site Identification activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Site Identification Questionnaires • Support the collection of country and site level intelligence