Clinical Trial Coordinator (CTC) or Assistant (CTA)

☞ Brainfield Switzerland

Vue: 209

Jour de mise à jour: 29-03-2024

Localisation: Chur Graubünden GR

Catégorie: Santé / soins médicaux

Industrie: Human Resources

Niveau: Entry level

Type d’emploi: Full-time

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le contenu du travail

Tasks
  • Collecting, registering and archiving information and documents in accordance with the applicable GCP (ISO 14155) guidelines for clinical studies;
  • Support the preparation and maintenance of TMF (trial master file) for the initiation of participating centers in clinical studies and during the execution and closing of the studies;
  • Participate in projects or initiatives on request, or on your own initiative, or take on department-wide tasks to contribute to the optimization of processes related to clinical trials
  • Co-responsible for maintaining the complete documentation for the studies and for correct study administration in accordance with the SOPs (Standard Operating Procedures), as well as the ICH-GCP guidelines.
  • Important tasks in study start-up, (digital) sending, tracing and administration as well as saving of essential documents (e.g. CRFs, CVs, study protocols, investigator brochures, informed consent forms etc).
  • May play a role in the filing of adverse effects.
  • Collaborate with clinical trial lead, assisting tasks will include setting up systems for filing, document management, document distribution and study management, and preparing, assembling and distributing study materials
  • Supports clinical trial lead with clinical study contract management
  • Data Management:
  • engaged in setting up and maintaining systems for device distribution, traceability and inventory control
  • order SD cards, SD card cases
  • formats SD cards
  • close follow up with clinical sites on supply status (MemoryBoxes, SD cards, consumables, sensors, ….etc)
  • Payments:
  • Creates and reviews reports for study center, DSMB member’s compensation and reimbursements
  • Identifies and resolves discrepancies
  • Insurance:
  • Track insurance policies and ensures that they are renewed
Requirements
  • High School Diploma and a minimum of 4 years of related experience (CTA), or Associated higher education and a minimum of 2 years of related experience (CTC)
  • Fluency in English (both written and spoken), German language skills are an advantage (desired)
  • Detail and quality oriented
  • Strong personal (very structured and detail oriented way of working), organizational and communication skills required
  • Good knowledge of MS Office, familiar with common computer applications such as word processing and spreadsheets and have knowledge of document filing systems is a plus
  • Manage multiple tasks and take ownership and workflow initiative
  • Assists with periodic audits of clinical study files for completeness and accuracy
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Date limite: 13-05-2024

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