Regulatory Affairs Study Start Up Specialist IICTI Clinical Trial and Consulting Services – Sydney NSWHybrid15d ago , from CTI Clinical Trial and Consulting ServicesPlease do not apply if you are not fully eligible to work in Australia.
CTI doesn't offer any Sponsorship.What you'll do:Assist/Advise project teams on all regulatory requirements for clinical studiesPerform compliance assessments according to country requirements and document any activity discovered;notify ProjectManagers of any findingsReview and adapt study specific documentsaccordingeach country and site requirementsPerform IRB/EC(CA)and/ or other Regulatory Bodiessubmissions on behalf of sponsors and and/or sites as agreed with the Sponsor andin accordance witheach 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,clarificationor 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 beforesubmittingto the sites,IRB/EC/CAand/or otherRegulatory Bodies according to the local requirementsAssistwith and adapt Informed ConsentForm (ICF) according to IRB/IEC requests on country or site levelAssistin preparation, quality check and filing of site adapted ICF according to local requirementsPrepare and QC Clinical Trial Application forms (e.g.CTA,XML)whereapplicableInteract with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested,



to Sponsorin accordance withCTI or Sponsor SOPsRespond to Deficiency Letters from IRB/IEC/CAand/ or other Regulatory Bodiesin liaison with sponsor and study PM orassistsites 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 withaccurateperiodic status reportsin accordance withCTI SOPs and attend internal and external project meetings as neededAccurately apply naming conventions,uploadand 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 SOPsAssistwith preparation for Sponsor or Agency audits and inspectionsAssist with QC and QA of various study related Regulatory documents and reportsOversee 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 meetingsSitesbudgetsand Sitescontracts management, dependingfromCountries/RegionsWhat you bring:Associate's or Bachelor's Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experienceA minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experienceOngoing willingness to learnDetail orientedAbility to collaborate well in an (international) team environmentExcellent verbal and written communication skillsFluent in oral and written English is a must,Ability to develop, prioritize, organize,



and manage multiple tasksDecision making and creative problem-solving skillsWorking knowledge and understanding of applicable country regulations, International Council on Harmonization (ICH) / Valuable Clinical Practice (GCP) regulations and guidelinesWhy CTI?
We support career progression – We Believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forwardWe value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training departmentWe value our people - We guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked.
We support a work-life balance and the importance of time with family by offering generous vacation time and a hybrid work from home scheduleOur culture is unparalleled – We've received multiple awards recognizing CTI as one of thebest places to work in the greater Cincinnati area, as well as one of thetop CROs in the industryWe think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work.
Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROsOur work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
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📌 Regulatory Affairs Study Start Up Specialist Ii (New South Wales)
🏢 CTI Clinical Trial and Consulting Services
📍 New South Wales