Clinical Trial Intern

Aptar; Rueil-Malmaison; Sur place; EUR 30 000 - 50 000; Plein temps

Résumé du poste

Une entreprise innovante recherche un stagiaire en essais cliniques pour gérer la documentation des études cliniques. Ce rôle clé implique de travailler en étroite collaboration avec les équipes cliniques et les sites d'étude pour garantir que les essais respectent les protocoles et les réglementations. Le candidat idéal doit avoir une formation scientifique et une attention particulière aux détails, avec la capacité de gérer des délais et des budgets. Ce poste offre une excellente opportunité d'apprendre et de contribuer à des projets ayant un impact significatif dans le domaine de la santé.

Qualifications

• Formation scientifique requise avec des connaissances en recherche clinique.
• Certification en recherche clinique souhaitée.

Responsabilités

• Gérer la documentation des études cliniques selon les bonnes pratiques cliniques.
• Surveiller les visites de sites pour assurer la conformité et la collecte de données.

Connaissances

Gestion de projet

Attention aux détails

Connaissance de la réglementation

Compétences en communication

Formation

Formation scientifique

Certification en recherche clinique (ACRP)

Outils

Systèmes de gestion des données d'essai clinique

Capture de données électroniques

Description du poste

Aptar Digital Health is a division of Aptar Pharma

A global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing, and active material science solutions and services.

Aptar Digital Health/Voluntis conducts medical device clinical studies as a Sponsor across several therapeutic areas and contributes to support the clinical and market access strategy of the Company, potentially with Pharma partners. This situation leads to the need for strong management of the clinical trials where documentation, trial site oversight, and monitoring progress are key factors for success.

The position of the Clinical Trial Intern (CTI) is to manage the documentation part of the study conduct rigorously and according to Good Clinical Practices and Standard Operating Procedures, with good collaboration with the study sites, Contract Research Organization, and the ADH/Voluntis teams as a Sponsor.

Under the supervision of the clinical project lead and in collaboration with the clinical team, the CTI will:

• Ensure the studies are done in compliance with protocols, standard operating procedures, and Good Clinical Practice (GCP) guidelines.
• Monitor regular site visits to oversee trial activities and data collection.
• Review and analyze clinical trial data for accuracy and completeness.
• Develop and maintain study timelines and budgets elaborated by the clinical project lead.
• Provide training to study staff on study protocols and GCP guidelines under delegation of the clinical project lead.
• Organize the Trial Master File.
• Respond to audits based on clinical study documentation.
• Collaborate with the site monitor, research coordinator, or investigator regarding study documentation.
• Conduct source data verification and ensure data quality.
• Manage trial supplies and device accountability.
• Serve as a liaison between study sites, sponsors, and regulatory agencies regarding study documentation.

Minimum Requirements:

• Trainee with a scientific background.
• Knowledge of regulatory requirements and guidelines, such as Good Clinical Practice (GCP) and Medical Device Regulation 2017/745/EC.
• Certification in clinical research, such as the Association of Clinical Research Professionals (ACRP) certification.
• Knowledge of clinical trial data management systems and electronic data capture.
• Experience with site selection, initiation, management, and monitoring activities.
• Strong attention to detail and accuracy in data management.
• Understanding of medical device development processes.
• Working knowledge of medical terminology.
• Project management and leadership skills with attention to detail.

Ability to work collaboratively with study teams and cross-functional departments.