Clinical Regulatory Start-Up Specialist I

About The JobManage essential Regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with, assist and advise the study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of essential regulatory documentation and to provide ongoing status reports about the documentation. Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs.About The JobManage essential Regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with, assist and advise the study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of essential regulatory documentation and to provide ongoing status reports about the documentation. Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs.What You'll DoAssist/advise project teams on all regulatory requirements for clinical studiesPerform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findingsReview and adapt study specific documents according each country and site requirementsPerform IRB/EC/CA and/ or other Regulatory Bodies submissions on behalf of sponsors and/or sites as agreed with the Sponsor and in accordance with each country requirementsReceive and process study documentation from sites, check content and quality as well as completenessInteract with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality reviewCompile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements, perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirementsAssist with and adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site levelAssist in preparation, quality check and filing of site adapted ICF according to local requirementsPrepare and QC Clinical Trial Application forms (e.g. CTA, XML), where applicableInteract with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPsRespond to Deficiency Letters from IRB/EC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirementsCompiling and assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as neededAccurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paperPerform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPsAssist with preparation for Sponsor or Agency audits and inspectionsAssist with QC and QA of various study related Regulatory documents and reports.Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scopeAttend internal and external study meetings and regulatory status reports for each site and country during study meetings Sites budgets and Sites contracts management, depending from Countries/RegionsRequired Education And ExperienceAssociate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experienceA minimum of 1 - 2 years of relevant pharmaceutical, site, or CRO Regulatory experienceCOMPETENCIESOngoing willingness to learnDetail orientedAbility to collaborate well in a team environmentAbility to maintain confidentialityProficient in use of computer and software systemsExcellent verbal and written communication skillsFluent in oral and written EnglishAbility to provide superior level of customer serviceAbility to develop, prioritize, organize, and manage multiple tasksDecision making and creative problem-solving skillsWorking knowledge and understanding of applicable country regulations, Inte