Regulatory & Study Start Up Specialist - UK - 0.7 FTE

RBW Consulting are partnered with a leading mid-sized CRO in their search for a Regulatory & Study Start Up Consultant to work remotely in the UK. This is an initial 4 month contract for an estimated 0.7 FTE. Rate is negotiable. Must haves Be proficient in preparing regulatory submissions in the UK (combined review through IRAS, Radiation assurance, ARSAC). Must have proven recent experience on this, and be able to work independently on this (ie: completing medicines form, radiation form, providing advice on required documents for regulatory submissions, etc). Be proficient in creating budget using Interactive Costing Tool (iCT) in CPMS. Be proficient in performing country adaptation for the UK for ICF’s. Duties Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. Interaction with CA/EC for study purposes and handling responses to the CA/EC. Providing regular updates about CA and EC submissions to Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant. Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. Prepare/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration. Review and manage collection of essential documents required for site activation/IMP release. Customize country/site specific Patient Information Sheet and Informed Consent Forms. Responsible for/facilitates the translation and co-ordination of translations for documents required for submission. Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables. Act as SME for collection and maintenance of site level critical path to IMP Release data points such as Competent Authority, local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country. When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. May support the clinical team performing Pre-Study Site Visits May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors. May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries. May interact with clients to provide activation readiness status updates, request documents or document review and participate in proposal activities, including slide development and client presentation as required. Consultant may be asked to undertake other related duties as may be needed. Apply here and Harry Henson will be in touch to discuss your application further!