Parexel FSP is seeking Clinical Trial Coordinators to join our team in Canada! Candidates should 1-2 years of experience in clinical research, bilingual in english and french and be open to go to sponsor's office in Montreal, Kirkland 2x/week.Job SummaryThe Clinical Trial Coordinator supports the Clinical Research Manager and other team members through the life cycle of the study from study start up to study closure.Key AccountabilitiesTrial and site administrationTracking (e.G., essential documents) and reporting (e.G., Safety Reports)Ensure collation and distribution of study tools and documentsUpdate clinical trial databases and trackersClinical supply & non-clinical supply management, in collaboration with other country rolesManage Labeling requirements and coordinate/sign translation change requestDocument ManagementPrepare documents and correspondenceCollate, distribute/ship, and archive clinical documentsAssist with electronic Trial Master File reconciliationUpdating manuals/documents (e.G., patient diaries, instructionsDocument proper destruction of clinical suppliesPrepare Investigator trial file bindersExecute electronic Trial Master File Quality Control PlanObtain translations of documentsRegulatory & Site Start Up ResponsibilitiesProvide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions in a timely mannerObtain,



track and update study insurance certificatesSupport preparation of submission package for Institutional Review Board / Ethics Review Committee and support regulatory agencies submissionsPublish study results for Global Clinical Trial Operations and Regulatory Affairs where required per local legislationBudgeting, Agreement And PaymentsDevelopment of country and site budgets (including Split site budget)Tracking and reporting of negotiationsMaintenance of tracking toolsWorking knowledge of contract development, negotiation, approval, and maintenance (e.G., Clinical Trial Research Agreements)Updating and maintenance of contract templates (in cooperation with Legal Department)Payment calculation and execution (investigators, vendors, grants)Ensuring compliance with financial proceduresMonitoring and tracking adherence and disclosuresBudget closeoutObtain and process Foreign Corrupt Practices Act documentation in a timely mannerMeeting PlanningOrganize meetings (create & track study memos/letters/protocols)Support local investigator meetings (invitations, prepare materials, select venue, support where applicable)Compliance With Parexel StandardsComplies with required training curriculumCompletes timesheets accurately and timely as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes,



ICH-GCPs and other applicable requirementsSkillsFluent in Local Languages and business proficient in English (verbal and written) and excellent communication skillsGood understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelinesHands on knowledge of Good Documentation PracticesGood IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills requiredInternational Council for Harmonization ‐ Positive Clinical Practice knowledge appropriate to roleEffective time management, organizational and interpersonal skills, conflict managementEffective communication with external customers (e.G., sites and investigators)High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environmentWorks effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.Demonstrates commitment to Customer focusAble to work independentlyProactive attitude to solving problems / proposing solutionsPositive mindset, growth mindset, capable of working independently with assigned tasksContributes to Clinical Trial Coordinator team knowledge by acting as buddy /mentor and sharing best practices as appropriate/requiredKnowledge And ExperienceMinimum 1-2 years in Clinical Research or relevant healthcare experience Note - Specific experience requirements may vary depending on the Country.EducationBachelor's degree (Life Sciences preferred) or equivalent healthcare experience

📌 Clinical Trial Coordinator (Regulatory) - Fsp (Quebec City)
🏢 Parexel
📍 Quebec City