Clinical Research Associate II

hace 1 mes

Alcobendas, Madrid, España Parexel A tiempo completo
Job Title: Initiation Clinical Research Associate II

About the Role:

The Initiation Clinical Research Associate II (iCRA II) plays a crucial role in the start-up phase of clinical trials, ensuring seamless execution and quality delivery. As a key member of the Parexel team, you will be responsible for managing and driving the strategy for Pre SIV / start-up tasks, collaborating with investigators and site staff to achieve project goals.

Key Responsibilities:

  • Act as Parexel's direct point of contact with assigned sites, ensuring quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff, fostering a collaborative environment.
  • Generate visit/contact reports, using judgment to identify site issues and problem-solving to direct resolution.
  • Develop strategies to configure, distribute, and collect high-quality country-specific and/or site-specific documents or essential regulatory documents (SRP).
  • Customize, review, and negotiate country/site-specific Informed Consent Forms (ICF), translations, and amendments.
  • 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/maintain Clinical Trial Management systems (CTMS).

Requirements:

  • Strong problem-solving skills and ability to work independently.
  • Client-focused approach to work, with excellent communication and interpersonal skills.
  • Ability to prioritize multiple tasks and achieve project timelines, utilizing strong analytical skills to make decisions autonomously.
  • Fluent command of Spanish and English languages.
  • Excellent time management to meet study needs, team objectives, and department goals.

Education and Experience:

  • Previous experience in study set-up/site initiation/study start-up or equivalent experience in clinical research environment, with understanding of clinical trials methodology and terminology.
  • 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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