Clinical Research Pharmacy
2 weeks ago
Posting closing date: November 11, 2024
Date de fin d’affichage : le 11 novembre 2024
Status : Regular, full-time
Statut :Régulier, temps plein
(Français à suivre)
Clinical Research Pharmacy (CRP) Support Specialist (CRPSS)
Role Summary
Role Responsibilities
- Manages the collection of responses gathered from clinical sites (e.g. site IP shipment receiving hours, contact details, IP storage capacity, investigator site IP handling capabilities) and supports CRP in the collection of information required for inspection readiness
- Provide project management support for IP handling initiatives to ensure project milestones are met from ideation through completion
- Supports the creation of shipment notification templates and IP handling reminders to investigator sites
- Coordinates review of study documents and information stored in Florence or a site’s equivalent system that maintains the electronic Investigator Site File (eISF) and other source documents (eSource) to support the reconciliation of IP usage at investigator sites
- Provides support to facilitate the submission of information required to resolve IP handling issues in a timely manner and escalates IP handling issues as needed
- Maintains effective communication with study team members (e.g., Pfizer and Clinical Research Organization (CRO) Study Managers, Clinical Research Associates and Site Care Partners, as needed), and appropriate Pfizer GCS colleagues throughout the duration of the study in order to ensure smooth coordination of IP to/from clinical sites
- Maintains project contact lists and supports other day to day IP handling activities as needed for problem solving/issue resolution
- Provides support in the creation of patient/site friendly IP handling tools (e.g. dosing instructions, IRT reference cards, videos, etc.) to ensure safe and correct use of IP in clinical trials
- Attends CRP team meetings and protocol specific trainings (e.g., Investigator Meetings, CRA trainings, site retraining sessions, etc.) as needed to facilitate the distribution of clinical trial operational information
- Assists with managing document uploads and maintaining an organized, user-friendly collaborative space in the CRP Teams site
Qualifications
- Bachelor’s degree.
- Demonstrated experience managing multiple, complex projects, developing successful partnerships and strong customer focus.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
- Strong attention to detail and exceptional organizational skills.
- Proven ability to adapt and adjust as needed. Team-oriented and flexible; daily tasks can rapidly shift.
- Able to build strong global and local networks across functions, lines, and departments.
- Demonstrated ability and initiative to work as part of a team as well as independently
- Ability to manage own time with limited supervision
- Capable of handling multiple tasks with tight deadlines in a matrixed, fast paced environment.
We are proud to offer employees a flexible working model that is grounded on empowering colleagues to design their workdays so that they can maximize their productivity, enhance their work-life balance and support a way of working that fosters innovation and patient-centricity. Currently, our employees are expected to be on-site 2.5 -3 days per week blending on-site collaboration and connection with off-site remote working when it makes business sense to do so.
- The annual base salary for this position ranges from _$64,500 to $107,500._
- Spécialiste du soutien - Pharmacie de recherche clinique coordonne les renseignements
Résumé du poste:
Le ou la spécialiste du soutien - Pharmacie de recherche clinique coordonne les renseignements liés à la manipulation des produits expérimentaux dans le cadre des études cliniques parrainées par Pfizer. Il ou elle travaille en étroite collaboration avec le pharmacien ou la pharmacienne de recherche clinique responsable de chaque programme et communique avec les collègues qui suivent pour coordonner efficacement les activités relatives à la manipulation des produits expérimentaux : le coordonnateur ou la coordonnatrice - Produits expérimentaux de Pfizer, l’équipe de gestion des études cliniques de Pfizer ainsi que les partenaires des relations avec les centres cliniques et les partenaires d’excellence des centres cliniques.
La personne titulaire du poste collabore étroitement avec le ou la responsable de la Pharmacie de recherche clinique au sujet des protocoles qui lui sont attribués et consulte d’autres collègues de l’Approvisionnement mondial, Fournitures cliniques (p. ex., les responsables de la chaîne d’approvisionnement, les spécialistes - Distribution, les spécialistes - Technologie de réponse interactive, etc.) pour coordonner les activités de la chaîne d’approvisionnement des fournitures cliniques qui se rapportent à l’expédition des prod
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