ASSIGNMENT PROFILEClinical Trial Coordinator (CTC)Description of Roles and ResponsibilitiesTrial and site administration:Tracking (e.g., essential documents) and reporting (e.g., Safety Reports)Ensure collation and distribution of study tools and documentsUpdate clinical trial databases (CTMS) and trackersClinical supply & non-clinical supply management, in collaboration with other country rolesManage labeling requirements and coordinate/sign translation change requestsDocument management:Prepare documents and correspondenceCollate, distribute/ship, and archive clinical documentsAssist with eTMF reconciliationUpdating manuals/documents (e.g., patient diaries, instructions)Document proper destruction of clinical suppliesPrepare Investigator trial file bindersExecute eTMF Quality Control PlanObtain translations of documentsRegulatory & Site Start-Up responsibilities:In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up, and submissionsObtain, track, and update study insurance certificatesSupport preparation of submission package for IRB/ERC and support regulatory agencies submissionsPublish study results for GCTO and RA where required per local legislationBudgeting, Agreement and Payments:Collaborate with finance/budgeting representatives for:Develop country and site budgets (including Split site budget)Tracking and reporting of negotiationsMaintenance of tracking toolsContract development, negotiation, approval, and maintenance (e.g., CTRAs)Update and maintain contract templates (in cooperation with Legal Department)Payment calculation and execution (investigators, vendors, grants)Ensure compliance with financial proceduresMonitor and track adherence and disclosuresBudget closeoutMeeting Planning:Organize meetings (create & track study memos/letters/protocols)Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)Experience RequiredMinimum 1-2 years in Clinical Research or relevant healthcare experience.
Note - Specific experience requirements may vary depending on the Country.Educational RequirementsB.A./B.S.
(Life Science preferred) or equivalent healthcare experience.CORE Competency ExpectationsFluent in Local Languages and business proficient in English (verbal and written) with 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 requiredICH-GCP Knowledge appropriate to roleBehavioural Competency ExpectationsEffective 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 relationshipsDemonstrates commitment to Customer focusAble to work independentlyProactive attitude to solving problems/proposing solutionsIQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Learn more at https://jobs.iqvia.com
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