Clinical Data Associate Jobs in Quebec (NOW HIRING)

Syneos Health est une organisation de premier plan, entierement integree, specialisee dans les services en sciences de la vie, concue pour accelerer le succes de ses clients. Nous collaborons avec des innovateurs a chaque etape du continuum du developpement et de la commercialisation des medicaments, en les aidant a naviguer dans la complexite, a anticiper le changement et a accelerer leurs progres.

Les membres de notre equipe Clinical Solutions adoptent une approche axee sur le developpement des medicaments, en mettant a profit leurs annees d'experience et leur expertise approfondie pour comprendre pleinement les besoins des clients et les refleter dans les solutions que nous concevons.

Que vous nous rejoigniez dans le cadre d'un partenariat de type Functional Service Provider ou dans un environnement full-service, vous collaborerez avec des professionnels passionnes par la resolution de problemes, en innovant en equipe pour aider nos clients a atteindre leurs objectifs. Nous sommes agiles et animes par la volonte de delivrer - les uns pour les autres, pour nos clients et, surtout, pour les patients qui en ont besoin.

Decouvrez ce que vos 25 000 futurs collegues savent deja :

Pourquoi Syneos Health

Nous sommes passionnes par le developpement de nos collaborateurs, grace a des opportunites d'evolution de carriere, un management de proximite engage et bienveillant, des formations techniques et therapeutiques, ainsi que des programmes de reconnaissance entre pairs et de remuneration globale.

Nous nous engageons a batir une culture inclusive, ou chacun peut etre pleinement lui-meme. Au cur de cette demarche se trouve notre raison d'etre - *Driven to Deliver* - qui reflete la passion de nos collaborateurs a proposer chaque jour des solutions capables d'avoir un impact significatif sur la vie des patients.

Nous construisons continuellement l'entreprise dans laquelle nous souhaitons tous travailler et avec laquelle nos clients souhaitent collaborer. Pourquoi ? Parce que nous savons qu'en reunissant des talents du monde entier, nous pouvons faconner l'avenir des soins de sante, generer un impact pour nos clients et accelerer les progres au benefice des patients.

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
• May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close out
  Knowledge of local requirements for real world late phase study designs
  Chart abstraction activities and data collection
  As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff
  Identify and communicate out of scope activities to Lead CRA/Project Manager
  Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
  Identify operational efficiencies and process improvements
  Develop country level informed consent forms
  Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
  Participate in bid defense meetings

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.
• Ability to manage required travel of up to 75% on a regular basis

Decouvrez Syneos Health

Au cours des cinq dernieres annees, nous avons collabore sur 94 % de tous les nouveaux medicaments approuves par la FDA, 95 % des produits autorises par l'EMA, ainsi que sur plus de 200 etudes menees sur 73 000 sites et impliquant plus de 675 000 patients.

Quel que soit votre role, vous ferez preuve d'initiative et remettrez en question le statu quo a nos cotes, dans un environnement hautement competitif et en constante evolution. Pour en savoir plus sur Syneos Health :

[http://www.syneoshealth.com](http://www.syneoshealth.com)

Informations complementaires

Les taches, fonctions et responsabilites decrites dans cette fiche de poste ne sont pas exhaustives. L'entreprise se reserve le droit, a sa seule discretion et sans preavis, d'assigner d'autres taches, fonctions et responsabilites. Une experience, des competences et/ou une formation equivalentes seront egalement prises en compte ; par consequent, les qualifications des titulaires du poste peuvent differer de celles indiquees dans la presente description. L'entreprise determinera, a sa seule discretion, ce qui constitue une equivalence aux qualifications mentionnees ci-dessus.

Par ailleurs, aucune disposition du present document ne doit etre interpretee comme creant un contrat de travail. Les competences et experiences requises peuvent parfois etre decrites de maniere succincte. Le contenu du present document vise a respecter pleinement les obligations legales applicables dans chaque pays ou l'entreprise opere, y compris la mise en uvre de la directive europeenne sur l'egalite en matiere de recrutement et d'emploi.

L'entreprise s'engage a respecter l'Americans with Disabilities Act (ADA), notamment en fournissant des amenagements raisonnables, lorsque cela est approprie, afin d'aider les employes ou les candidats a exercer les fonctions essentielles du poste.