Clinical Research Associate II

hace 3 días

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

The Initiation Clinical Research Associate II (iCRA II) plays a crucial role in the success of clinical trials at Parexel. This position is responsible for performing all study start-up activities, ensuring timely and high-quality execution.

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, fostering a collaborative environment.
  • Generate visit/contact reports, identifying site issues and resolving them through effective problem-solving.
  • Develop strategies to configure, distribute, collect, review, and approve 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 follow-up actions.
  • 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.
  • Able 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.
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, including experience with EU CTR.

Good previous Clinical Site Agreement (CSA) and site contracts experience is desirable.

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