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Site Care Partner - Home Based (US or Canada)

Site Care Partner - Home Based (US or Canada)

Pharmaceutical Research Associates, IncMexico
Hace 4 días
Tipo de contrato
  • Teletrabajo
Descripción del trabajo

Overview

As a Site Care Partner you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing :

  • Responsible for relationship building and operational oversight of the site.
  • Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g., vendor, site contracts and payment issues etc.).
  • Ensure the strategy / approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study.
  • Be accountable for effective site recruitment planning and delivery, consistent with global and / or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators.
  • Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals (recruitment, data entry timelines etc).
  • Partner with local RA / CTRO / SAP to ensure timely completion on country / local registry when applicable.

En quoi consistera votre travail :

  • Accompagner les centres d’étude dans leur activation et dans les activités de l’étude, du début à la clôture de l’étude.
  • Maintenir des communications régulières avec les centres d’étude pour obtenir des mises à jour sur leurs progrès, des évaluations non officielles ou officielles sur le rendement, ainsi que des commentaires au sujet de l’étude.
  • Agir en tant que personne-ressource principale pour toutes les questions concernant les centres d’étude et l’étude, en assurant la liaison avec les équipes appropriées, afin de répondre aux questions et résoudre les problèmes. Effectuer le suivi et informer les chercheurs du statut des problèmes, afin de s’assurer qu’ils sont au courant de leur résolution.
  • Informer et éduquer les centres d’étude au sujet des occasions de participer à des études de recherche du portefeuille de Pfizer qui pourraient leur convenir.
  • Diriger de manière efficace la planification du recrutement des centres et la mise en œuvre de plans au niveau du pays et du centre, conformément au plan mondial et aux objectifs locaux
  • Qualifications

    You are : Education

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years experience).
  • Proficiency in local language preferred. English is required.
  • 5-7 years clinical experience (this includes clinical monitoring)
  • Experience with audits is preferred but not required
  • Study start up experience required
  • Skills and Technical Competencies

  • Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements.
  • Must demonstrate good computer skills and be able to embrace new technologies.
  • Good communication, presentation and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.
  • Demonstrated networking and relationship building skills.
  • Demonstrated ability to manage cross functional relationships.
  • Ability to communicate effectively and appropriately with internal & external stakeholders.
  • Ability to adapt to changing technologies and processes.
  • Knowledge of country requirements for GCP that may be different to those of Procedures.
  • Ce que vous devez posséder :

  • Connaissances avérées des exigences en matière de qualité et de réglementation pour les pays applicables.
  • Connaissances avérées des renseignements sur les centres au niveau du pays / des groupes, à l’appui des recommandations relatives aux centres.
  • Connaissances avérées des méthodes utilisées dans les essais cliniques et du processus de développement des médicaments, en ce qui concerne le suivi des essais cliniques, les BPC, la FDA ou l’environnement réglementaire spécifique à un pays.
  • Réussite avérée dans des postes scientifiques / techniques / administratifs antérieurs.
  • Expérience avérée dans l’activation des centres.
  • Compétences avérées en matière de réseautage et de développement de relations.
  • Capacité avérée à gérer des projets et des processus interfonctionnels.
  • Capacité à communiquer de manière efficace et appropriée avec les intervenants internes et externes.
  • Capacité à s’adapter à l’évolution des technologies et des processus
  • What ICON can offer you : Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include :

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
  • Visit our careers website to read more about the benefits of working at ICON : https : / / careers.iconplc.com / benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https : / / careers.iconplc.com / reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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