Job Title

Clinical Trial AssociateThe Clinical Trial Associate will be responsible for setting up, tracking and maintaining Clinical Site related documents. You will help manage and review regulatory documents as well as maintain the Local Study File. Assist with coordinating the distribution, retrieval and review of regulatory documents required for the initiation of the Clinical Study, through maintenance, and close-out.Performs the role of Clinical Trial Assistant (CTA) supporting the Local Trial Manager and Site Manager to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials. Performs regulatory document review and approval, including site specific Informed Consents. Ensures trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements. May contribute to process improvement, training and mentoring of other CTAs.ResponsibilitiesResponsible for study start-up activities, including creating site folders, collating, preparing and maintaining (e)SIP documents, updating systemsLiaise with clinical sites to collect, review and track feasibility questionnairesCo-ordinates entry and maintain local data into study management systems (eClinical, CDSS/CDSS-R, SADMS, etc) including setting up new studies in eClinicalAct as a back-up for other Supplier CTAsEnsures collection, review, track and provision of appropriate clinical documents to support regulatory submission and to perform IRB/IEC submissions including when appropriate preparation and submission of all documents to the central and/or local committeeTrack and maintain adequate study related supplies in the office and facilitate their distribution to sites, including preparing and distributing Study File Binders, study drugs and Site Initiation presentations/materialsOrganize and participate in Investigator meetings and monitor workshops as required within budget guidelinesProvides support to responding to local audits and inspectionsProcesses, reconciles, distributes and tracks essential documents and submits them to RIM/EPIC or local archive in compliance with SOPsHas ability to process SIPs and forward to Regulatory/RIM within 5 business days from the date of SIP approval. Follow eSIP processCompletes tracking documentation as applicable including but not limited to spreadsheets, study and contract trackerOrders, processes and tracks Case Report Forms (CRF) and follows up on query resolution if required to do soManage local distribution of Investigator BrochurePrepare and review site communication documents; facilitate mass mailings/faxesProvide administrative support such as word processing, photocopying, faxing, filing, managing correspondence, presentations preparation, basic computer software supportSet-up/maintain courier accounts and organize shipments (including but not limited to frozen samples) as requiredInteracts with Clinical Research Services Manager for project or study related workSupports the execution of clinical studiesResponsible for study start up activitiesTracks study related documentsManages logistics and document exchange between clinical sites and sponsorActively contributes to results oriented department goalsDrives continuous improvement of GCSMPromotes operational and scientific excellence within local GCSMIdentifies opportunities and best practices with local and regional partners that willcontribute to overall operational effectivenessResponsibilities may include Lead CTA activities as required. Activities may include but are not limited to:Works with the CTA Line Manager to complete delegated tasks from the Quality Oversight PlanWorks with the CTA Line Manager and sponsor groups to develop policies and practices relevant to the CTA groupProvides mentorship and training to newly hired CTAs and other CTAs as requiredParticipate, contribute and collaborates to share best practices across the program including action planning and support for addressing and resolving challengesRequirements1 to 2 years of clinical research experienceMaintenance of the Trial Master FileStudy Start Up and REB Submissions (including ICF review)Essential Document Collection and ReviewAbility to operate and use various systems and databasesSite experience as a study coordinator or research assistant, or previous CTA experience with CRO/sponsorExperience with IRB/REB submissions; experience with local and/or central REBsExperience with ICF forms, review and submission process to ethicsAn understanding of regulatory requirements in Canada (i.e. CTSI form, Health Canada submissions)Be able to work independently without the need for constant direction from LTMBe able to work on multiple trials at once and across therapeutic areasExcellent communication skills and able to work with several different study teams at onceBe able to organize and prioritize efficiently so that timelines and deliverables are metSelf-starter and able to work effectively from home (i.e. Home office set up/working space)Preferably located in same time zone or able to work regular business hours in EST zone (i.e. Ontario/Quebec)Strong understanding of ICH/GCPStrong attention to detailWhat ICON Can Offer YouOur success depends on the quality of our people. Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our Benefits Examples IncludeVarious annual leave entitlementsA range of health insurance offerings to suit you and your familys needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-beingLife assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among othersVisit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles.