Clinical Trial Specialist

hace 2 días


Madrid, Madrid, España Ora A tiempo completo

Overview

Ora is a leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research to efficiently bring new products and therapies to market.

About the Role

The Clinical Trial Associate II (CTA II) assists Project Managers in clinical study conduct for ophthalmic projects. Responsibilities include overseeing feasibility, generating contracts and budgets, collecting regulatory documents, and ensuring compliance with GCP protocol and overall clinical objectives.

Duties

  • Ensure study documentation, communication, training, and data collection adhere to study protocol and applicable SOPs, regulations, and guidelines.
  • Develop study-related documents, such as informed consent forms, source documents, and study logs.
  • Participate in all phases of clinical trial site management, from start-up to close-out activities.
  • Collect and review site regulatory documents for accuracy and completion.
  • Prepare essential documents packages for investigational product release and study/site approval submissions.
  • Create regulatory packages for IRB/IEC study and site submission.
  • Maintain the Trial Master File/electronic Trial Master File and file-sharing platforms.
  • Assist project managers in preparing study reports and collecting site status updates and study metrics.

Requirements

Candidates should possess excellent communication and organizational skills, with the ability to work autonomously and independently.

Compensation

The estimated annual salary for this position is approximately €35,000 - €55,000, depending on experience and qualifications.

About Ora

Ora values prioritizing kindness, operational excellence, cultivating joy, and scientific rigor. We prioritize employee well-being and offer a range of benefits to support our team members' success.



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