Clinical Research Associate II Specialist

hace 4 semanas


Madrid, Madrid, España Parexel A tiempo completo

Job Summary: We are seeking a highly skilled Clinical Research Associate II to join our team at Parexel. As a key member of our clinical research team, you will be responsible for performing all study start-up activities for clinical trials.

Key Responsibilities:

  • Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff.
  • Generate visit/contact reports, using judgment to identify site issues and problem-solving to direct resolution.
  • Develop strategy to configure, distribute, and collect, and review and approve, high-quality country-specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
  • Customize, review, and negotiate as needed, country/site-specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
  • Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, 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.
  • Update and maintain appropriate Clinical Trial Management systems (CTMS).
  • Skills:
    • Strong problem-solving skills.
    • Able to take initiative and work independently, and to proactively seek guidance when necessary.
    • Client-focused approach to work.
    • Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decisions autonomously due to the unpredictable nature of the issues that arise.
    • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
    • Fluent command of Spanish and English languages.
    • Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables.
    • Excellent time management to meet study needs, team objectives, and department goals.

Requirements:

  • Previous experience in study set-up/site initiation/study start-up experience 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.
  • 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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