Clinical Research Associate Specialist

hace 1 semana

Sevilla, Sevilla, España Pharmiweb A tiempo completo
Job Title: Initiation Clinical Research Associate

The Initiation Clinical Research Associate plays a crucial role in the success of clinical trials by ensuring a smooth start-up process. This position involves working closely with investigators, site staff, and other stakeholders to configure, distribute, and collect high-quality documents and essential regulatory documents.

Key Responsibilities:
  • Act as the primary point of contact for assigned sites, ensuring quality and delivery during the start-up phase.
  • Build and maintain relationships with investigators and site staff to facilitate effective communication and collaboration.
  • Generate visit/contact reports, using judgment to identify site issues and problem-solving to direct resolution.
  • Develop and implement strategies to configure, distribute, and collect country-specific and/or site-specific documents or essential regulatory documents.
  • Customize, review, and negotiate informed consent forms, translations, and amendments as needed.
  • Prepare and submit IRB/IEC and MoH/RA application(s), resolving conflicts and determining appropriate follow-up until receipt of final approval.
  • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
  • Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH/RA submission/approval, site activation, patient recruitment & retention, and update and maintain clinical trial management systems.
Requirements:
  • Strong problem-solving skills and ability to work independently.
  • Client-focused approach to work and ability to prioritize multiple tasks and achieve project timelines.
  • Fluent command of Spanish and English languages.
  • Excellent time management and ability to meet study needs, team objectives, and department goals.
  • Previous experience in study set-up/site initiation/study start-up or equivalent experience in clinical research environment.
  • Good previous Clinical Site Agreement (CSA) and site contracts experience is desirable.
  • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.

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