Attaché de recherche clinique II, Oncologie

IQVIA est à la recherche d'un associé de recherche clinique II avec une expérience en surveillance en oncologie basé dans l'Est du Canada. Doit être bilingue en français et en anglais.**Aperçu du poste**Surveiller et gérer les centres pour s’assurer qu’ils réalisent les études et produisent des rapports sur les données d’étude conformément au protocole d’étude, aux règlements et aux lignes directrices applicables, et aux exigences du promoteur. **Fonctions essentielles** S’assurer que les copies/originaux (selon les besoins) des documents du centre sont ajoutés au dossier principal d'essai (DPE) et vérifier que le dossier du centre de l’investigateur (DCI) est conservé conformément aux BPC et aux exigences réglementaires locales. Le cas échéant, superviser la gestion financière du centre conformément à l'accord d'essai clinique signé et récupérer les factures conformément aux exigences locales. **Diplômes et expérience** Au moins 2ans d’expérience en surveillance sur place. Une combinaison équivalente d’études, de formation et d’expérience peut aussi être acceptée. * C'est-à-dire les lignes directrices des bonnes pratiques cliniques (BPC) et du Conseil international d’harmonisation (CIH).* Bonne connaissance des thérapies et protocoles, tels que présentés dans la formation en entreprise.* Maîtrise écrite et verbale de l'anglais et du français* Gestion efficace du temps et des finances.* Capacité à établir et à entretenir des relations de travail efficaces avec les collègues, les gestionnaires et les clients.* Vous devrez soutenir, assurer la liaison avec et/ou travailler avec des [clients et/ou fournisseurs] d’IQVIA partout au Canada et à travers le monde, par conséquent, une connaissance fonctionnelle de l'anglais, tant à l'écrit qu'à l'oral, est nécessaire à l'exercice des fonctions de ce poste.Bonne connaissance et aptitude à appliquer les exigences réglementaires applicables en matière de recherche clinique. Compétences informatiques, y compris la maîtrise de Microsoft Word, Excel et PowerPoint et de l'utilisation d'un ordinateur portable ainsi que d'un iPhone et d'un iPad (le cas échéant). Solides compétences en matière d’organisation et de résolution de problèmes. * Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.* Trains site staff on the EDC system and verifies site computer system.* Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.* Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.* Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.* Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.* Perform SAE review and reconciliation* May review protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager and/or Lead CRA.* Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.* Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.* May assist with, and attend, Investigator Meetings for assigned studies.* Attends study-related, company, departmental, and external meetings, as required.* May serve as mentor for new clinical study monitors.* Authorized to request site audits due to data integrity concerns.* Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.* Ensure all study deliverables are completed per IQVIA Biotech and study timelines.* Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.* Assists with, and attends, Investigator Meetings for assigned studies.* Train site staff on the EDC system and verify site computer system.* Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.* Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.* Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.* Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.* May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.* May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.* Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.* Assist the study management in identifying and generating changes in scope* Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.* Authorized to request site audits due to data integrity concerns.* Attend study-related, company, departmental, and external meetings, as required.* Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.* Ensure all study deliverables are completed per IQVIA Biotech and study timelines* Conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.* Serve as mentor for junior CRAs and those new to the company and/or study.* Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.* Review and approve CRA travel expenses and time sheets.* Perform other duties, as requested.* Knowledge of clinical research process and medical terminology.* Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.* Good organizational and interpersonal skills.* Ability to reason independently and recommend specific solutions in clinical settings.* Ability to understand electronic data capture including
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