The Senior Clinical Research Associate manages assigned clinical trial sites to ensure patient safety, data quality, and adherence to protocols and regulatory standards. They act as the primary point of contact for investigators, providing training, monitoring site activities, and resolving operational issues throughout the study lifecycle.
Accompagner et former les adjoint·e·s de recherche clinique qui lui sont assigné·e·s Faire office d’expert·e pour les processus liés à l’ARC Participer à des groupes de travail ou à des initiatives d’amélioration des processus à l’échelle régionale ou locale Exercer des activités sous la direction d’un ou d’une partenaire responsable du centre de recherche avant l’activation du centre de recherche, dont la faisabilité et la sélection du centre, les évaluations préalables aux essais (PTA, pour Pre-Trial Assessment), la coordination des éléments de la liste de vérification de l’activation des centres, la mise au point des formulaires d’information et de consentement (FIC) et les visites d’activation des centres (SIV, pour Site Initiation Visit), selon le cas, ce qui comprend la gestion des problèmes pouvant retarder l’activation des centres Mener des activités de surveillance conjointe s’il y a lieu
Baccalauréat en sciences de la vie ou diplôme professionnel en sciences de la vie (sciences infirmières, pharmacie, médecine ou équivalent) Vaste connaissance des méthodes d’essais cliniques, de la Conférence internationale sur l’harmonisation des bonnes pratiques cliniques (ICH-GCP), des règles de la FDA et des règlements locaux Expérience en surveillance : au moins trois années d’expérience pertinente en surveillance de centres de recherche clinique (de préférence deux années en oncologie) Expérience thérapeutique souhaitée en oncologie, en vaccins, en médecine interne ou en maladies infectieuses Expérience dans le domaine des essais cliniques d’envergure mondiale Maîtrise de l’anglais et de la ou des langues maternelles du pays dans lequel il ou elle travaillera Un niveau avancé d’anglais, tant à l’oral qu’à l’écrit, est requis afin de permettre à la personne de collaborer efficacement avec des collègues et partenaires situés ailleurs au Canada et à l’international de façon quotidienne dans le cadre de ses responsabilités. APTITUDES PHYSIQUES OU MENTALES Connaissance approfondie des méthodes des études et du développement clinique, et capacité de maîtriser les détails des processus Connaissance établie des exigences de la réglementation locale et mondiale Compréhension approfondie des principaux éléments opérationnels de la recherche clinique (p. ex. surveillance, acquisition et classement des données, déclarations, etc.) Connaissance approfondie des maladies et des domaines techniques se rapportant aux études cliniques, y compris la direction de l’entreprise, les produits étudiés et les plans de développement associés Aptitude éprouvée à participer aux interactions avec l’équipe de réglementation du parraineur et les interactions et inspections réglementaires Connaissance établie des processus entourant la conception du protocole et l’évaluation de faisabilité Compréhension avérée de la culture et de la pratique médicale de la région/du pays et de leur incidence sur l’exécution de l’étude clinique Capacité démontrée à travailler dans une équipe matricielle et à influencer, à motiver et à diriger les autres en vue de favoriser la mise en œuvre réussie de l’étude clinique Capacité avérée à évaluer, à interpréter et à présenter des questions et des données complexes pour soutenir la gestion et l’atténuation des risques Aptitudes pour la communication orale et écrite avec ses collègues et d’autres intervenantes et intervenants à l’intérieur et à l’extérieur de l’entreprise HORAIRE DE TRAVAIL, DÉPLACEMENTS OU ENVIRONNEMENT NON STANDARDS Quantité importante de déplacements (de 60 à 80 %) au sein de la région. Possibilité de voyages internationaux et durant la fin de semaine. Passeport et permis de conduire valide Le salaire annuel de base pour ce poste varie de 73,650 $ à 122,750 $. L’échelle salariale fournie s’applique seulement au Canada, et ne s’applique à aucun autre endroit à l’extérieur du Canada. ------------------------------------------------------------------------------------------- Senior Clinical Research Associate I The Senior Clinical Research Associate I is responsible for the site management, site monitoring and closeout of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards. The Senior Clinical Research Associate I role is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The Senior Clinical Research Associate I is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner, and other members of the study team, as required, in activities associated with the set-up, running and close out of sites in a clinical trial. Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site initiation through to database lock, ensuring relevant timelines and quality deliverables are met During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks Attend investigator meetings when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the Study Monitoring Plan, SOPs and commensurate with emerging issues and technologies. Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities. Support database release as needed May undertake the responsibilities of an unblinded monitor where required. Clinical/Scientific and Site Monitoring Risk: Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team Interact with investigator site heath care professionals in a manner which enhances Pfizer’s credibility, scientific leadership and in order to facilitate Pfizer’s clinical development goals Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators Drive Quality Event remediation, when applicable Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable Other: Mentor/train Clinical Research Associates as assigned Serve as an SME for CRA-related processes Participate in regional or local working groups/process improvement initiatives Perform activities under guidance of a Site Care Partner prior to site activation e.g. feasibility and site selection, PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation Conduct co-monitoring activities as requested
Candidates must hold a bachelor's degree in life sciences and possess at least three years of clinical research site monitoring experience. Proficiency in English and knowledge of ICH-GCP guidelines and local regulatory requirements are essential.
Market context
In Alberta, Senior Clinical Research Associate I roles typically require hands-on site-monitoring experience, strong ICH-GCP knowledge, and familiarity with local regulatory requirements. Candidates can be more competitive when they clearly document at least three years of monitoring work, a life-sciences bachelor’s degree, and English proficiency; the listed salary range is CAD 73,650–122,750 annually. The requirements and benefits shown here are AI-summarized from the original description, saving research time—verify details before applying.