- 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 International Conference on Harmonisation Good Clinical Practice, Sponsor Standard Operating 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 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, Head Quarters functional areas and externally with vendors and Institutional Review Board/Institutional Review Committee 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.
- Supports audit/inspection activities as needed.
- Performs co-monitoring where appropriate.
- Fluent in English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonisation Good Clinical Practice & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Associate Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Developing skills in Site Management including management of site performance and patient recruitment.
- Developing level of monitoring skill and independent professional judgment.
- Good IT skills (Use of Microsoft office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Works with high quality and compliance mindset.
- Capable of managing complex issues, solution-oriented approach.
- Ability to perform root cause analysis and implement preventative and corrective action.
- Effective time management, organizational and interpersonal skills, conflict management
- Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
- High sense of accountability/ urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Positive mindset, growth mindset, capable of working independently and being self driven.
- Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
- B.A./B.S. required with strong emphasis in science and/or biology.
- M in. 2 years of clinical research experience. Related Clinical Research experience may include Clinical Trial Assistant, Study Coordinator, Regulatory Clinical Trial Coordinator or similar.
- Ability to travel domestically and internationally approximately 65%-75% of working time.
- Expected travelling 2-3 days/week.
- Current driver's license preferred.
- Bâtir des relations solides avec les centres et assure la pérennité de ces relations pendant toutes les phases de l'étude.
- Effectuer des activités de surveillance et de gestion des centres d'étude clinique en conformité avec les bonnes pratiques cliniques de la Conférence Internationale sur l'Harmonisation, les modes opératoires normalisés du commanditaire, les lois et règlements locaux, le protocole, le plan de surveillance des centres et les documents connexes.
- Acquérir une compréhension approfondie du protocole de l'étude et des procédures connexes.
- Coordonner et gérer diverses tâches en collaboration avec d'autres employés du commanditaire pour assurer la préparation des centres.
- Participer à la sélection des centres et aux activités de validation et communiquer ses points de vue à cet égard.
- Réaliser des activités de surveillance et de supervision à distance et sur place en utilisant divers outils pour s'assurer que: les données générées aux centres sont complètes, exactes et impartiales; les droits, la sécurité et le bien-être des sujets sont protégés.
- Effectuer des visites des centres, y compris des visites de validation, de mise en route, de surveillance et de clôture; produire des rapports de contacts lors de visites et hors visites clairs, complets et précis de manière appropriée et en temps opportun.
- Recueillir les documents réglementaires requis pour le démarrage, la poursuite et la clôture des études, les examiner et en faire le suivi.
- Communiquer avec les chercheurs et le personnel des centres concernant divers problèmes liés à l'application des protocoles, au recrutement, à la conservation, aux écarts par rapport aux protocoles, à la documentation réglementaire, aux vérifications/inspections des centres et au rendement général de ceux-ci.
- Cerner, évaluer et résoudre les problèmes de rendement, de qualité ou de conformité dans les centres et les acheminer aux échelons supérieurs, conformément au processus établi pour les associés de recherche clinique, au besoin et en collaboration avec le gestionnaire des associés de recherche clinique, le chef, Recherche clinique, le chef du secteur thérapeutique et le directeur, Recherche clinique, au besoin.
- Travailler en partenariat avec les opérations nationales des Opérations mondiales d'essais cliniques; les équipes des finances, des affaires réglementaires, de la pharmacovigilance et des affaires juridiques; les opérations régionales et les domaines fonctionnels du siège social, de même qu'à l'externe avec les fournisseurs, les Conseil d'examen institutionnel/Comité d'examen institutionnel et autorités de réglementation et les organismes de réglementation en soutien aux centres désignés.
- Gérer et tenir à jour l'information et la documentation dans les systèmes de gestion des essais cliniques, dossier principal d'essai électronique et une variété d'autres, selon les besoins et dans le respect des échéanciers.
- Appuyer les activités de vérification/d'inspection au besoin.
- Effectuer une surveillance conjointe s'il y a lieu.
- Maîtrise de l'anglais (à l'oral et à l'écrit) et excellentes aptitudes pour la communication, y compris capacité à comprendre de l'information technique. Capacité à développer ses compétences pour la présentation d'information technique avec du soutien.
- Bonne compréhension et connaissance pratique de la recherche clinique, des phases des essais cliniques, des les bonnes pratiques cliniques de la Conférence Internationale sur l'Harmonisation, ainsi que des lois et lignes directrices du pays qui s'appliquent à la recherche clinique.
- Bonne compréhension des lignes directrices mondiales/nationales/régionales qui concernent les associés de recherche clinique et capacité de travailler en respectant ces lignes directrices.
- Connaissance concrète des bonnes pratiques en matière de documentation.
- Capacité à développer ses compétences en gestion de centre, y compris la gestion du rendement et le recrutement des patients.
- Capacité à développer ses compétences pour la surveillance et son aptitude à exercer son jugement professionnel de manière indépendante.
- Bonnes compétences informatiques (utilisation de Microsoft Office, utilisation de certaines applications informatiques cliniques sur ordinateur, tablettes et appareils mobiles) et capacité à s'adapter aux nouvelles applications informatiques sur différents appareils.
- État d'esprit axé sur la haute qualité et la conformité.
- Capacité à gérer des problèmes complexes en adoptant une approche axée sur les solutions.
- Capacité d'effectuer une analyse des causes profondes et de mettre en œuvre des mesures préventives et correctives.
- Gestion efficace de son temps, compétences organisationnelles et interpersonnelles et aptitudes pour la gestion des conflits.
- Capacité à travailler avec d'autres professionnels de la recherche expérimentés pour développer ses compétences grâce à l'exposition à de multiples protocoles, centres et domaines thérapeutiques.
- Sens élevé des responsabilités/de l'urgence. Capacité à établir les priorités et à gérer plusieurs tâches simultanément dans un environnement en constante évolution, avec le soutien de son supérieur hiérarchique.
- Capacité à travailler efficacement dans un environnement multiculturel matriciel. Capacité à établir et à maintenir des relations de travail en faisant preuve de sensibilité aux particularités culturelles.
- Engagement à l'égard de l'orientation client.
- Attitude positive, mentalité axée sur la croissance, capacité à travailler de manière indépendante, sens de l'autonomie.
- Attitude professionnelle et style de communication conformes aux politiques et aux pratiques organisationnelles.
- B.A./B. Sc. avec accent marqué sur les sciences et/ou la biologie.
- Au moins deux ans d'expérience en recherche clinique. Une expérience connexe en recherche clinique peut avoir été acquise en tant qu'assistant d'essai clinique, coordonnateur d'étude, coordonnateur, Réglementation relative aux essais cliniques ou autres postes similaires.
- Capacité à voyager au pays et à l'étranger environ 65 % à 75 % du temps de travail, soit environ deux ou trois jours par semaine.
- Permis de conduire en vigueur, un atout.
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Associate Clinical Research Associate - Penticton, Canada - Merck
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Description
Job Description
Associate Clinical Research Associate (West)
Location: We are currently recruiting two positions in the Western Canada - 1 in Vancouver & 1 in Winnipeg
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.
With support of Senior Clinical Research Associate/Clinical Research Associate and/or Clinical Research Associate Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.
Responsibilities include but are not limited to:
Competency Expectations:
Behavioral Competency Expectations:
Education:
Extent of Travel:
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
Associé(e) adjoint(e), Recherche clinique (Région de l'Ouest)
Lieu: On comble deux postes à l'Ouest du Canada - 1 à Vancouver et 1 à Winnipeg
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.
Avec le soutien de l'associé principal, Recherche clinique/associé, Recherche clinique et/ou du gestionnaire des Associés adjoints, Recherche clinique, le titulaire du poste agit comme principal point de contact et gestionnaire dans les centres désignés pendant toutes les phases de l'étude de recherche clinique.
Compétences attendues:
Compétences comportementales attendues:
Éducation:
Déplacements à prévoir:
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 à favoriser un milieu de travail inclusif et diversifié.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
RemoteShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
06/11/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:06/11/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R297413