Associé(e), Recherche clinique

at  Merck Canada inc

Job Description
Notre équipe de recherche clinique et de pharmacovigilance repousse les limites de la santé mondiale grâce à la recherche et à l’innovation. Grâce aux essais cliniques et à la surveillance, nous garantissons la sécurité et l’efficacité de nos produits existants et en cours de développement pour produire des médicaments sûrs, efficaces et innovants.
Associé(e), Recherche clinique
Lieu: Montréal ou la Ville de Québec
Le/la titulaire de ce poste est responsable de l’exécution et de la conformité pour les protocoles et les centres attribués dans un pays. Sous la supervision du directeur associé, Recherche clinique, le titulaire du poste assure la conformité de la conduite des études avec les règlements relatifs aux Bonnes pratiques cliniques de la Conférence internationale sur l’harmonisation, les règlements du pays, les politiques et procédures de notre entreprise, les normes de qualité et les exigences de déclaration des effets indésirables, tant à l’interne qu’à l’externe.
Le/la titulaire du poste agit comme principale personne-ressource et gestionnaire principal pour les centres pendant toutes les phases d’une étude de recherche clinique, et assume la responsabilité générale des centres attribués.
Il/elle développe et élargit activement le territoire pour la recherche clinique, trouvant et formant de nouveaux centres.
Il/elle participe à des réunions internes et à des flux de travail en tant qu’expert en la matière pour la surveillance des processus et des systèmes.

SECONDARY LANGUAGE(S) JOB DESCRIPTION:

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
Clinical Research Associate
Location: Montreal or Quebec City
The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the Clinical Research Associate manager the person ensures compliance of study conduct with the International Conference on Harmonisation Good Clinical Practice and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new sites.
Participates in internal meetings and workstreams as subject matter expert for monitoring processes and systems.

EDUCATIONAL REQUIREMENTS:

B.A./B.S. with strong emphasis in science and/or biology
NOTE: We are currently recruiting 4 positions based either in Montreal or Quebec City
Nous sommes fiers d’être une entreprise qui embrasse la valeur de rassembler des personnes diversifiées, talentueuses et engagées. La façon la plus rapide d’innover est de rassembler des gens de diverses opinions dans un environnement inclusif. Nous encourageons nos collègues à remettre en question avec respect les problèmes de réflexion et d’approche de l’un et de l’autre. Nous sommes un employeur souscrivant au principe de l’égalité d’accès à l’emploi et nous sommes déterminés

Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performs clinical study site management/monitoring activities in compliance with the International Conference on Harmonisation Good Clinical Practice, Sponsor Standard Operation Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gains an in-depth understanding of the study protocol and related procedures.
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Participates & provides inputs on site selection and validation activities.
Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased. And that the subjects’ right, safety and well-being are protected.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined Clinical Research Associate Escalation Pathway as appropriate in collaboration with Clinical Research Associate Manager, Clinical Research Manager, Therapeutic Area Head and Clinical Research Director as needed.
Works in partnership with Global Clinical Trial Operations Country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarters functional areas and externally with vendors and Institutional Review Boards/Institutional Ethics Committees and Regulatory Authorities in support of assigned sites.
Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines.
Contributes to Clinical Research Associate team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required.
Supports and/or leads audits/inspection activities as needed.
Performs co-monitoring visits where appropriate.
Following the country strategy defined by Clinical Research Director and/or Clinical Research Associate manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.