Bryn Hagley

Site Activation Specialist @Worldwide Clinical Trials

Portland, OR, US

Track study-specific site regulatory documents by site and/or country and follow up with sites or internal team members as needed and report to the Site activation 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 the first review of required study-specific site regulations/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 on the 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 biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate•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•Support the development of a preliminary potential site list•Be familiar with and comply with SOPs, ICH GCP and applicable regulations