INITIATION CLINICAL RESEARCH ASSOCIATE I - King Of Prussia Pennsylvania

Company: PAREXEL
Location: King Of Prussia, Pennsylvania
Posted On: 11/12/2024

The Initiation Clinical Research Associate (iCRA) specializes in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCRA II can also support protocol amendments if applicable. This role involves performing all study start up activities for a clinical trial. Key Accountabilities: Start-Up (from site identification through pre-initiation)

• 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 decision 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 Dutch and English.
  • 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. Knowledge and Experience:
    • 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.
    • Good previous Clinical Site Agreement (CSA) and site contracts experience is desirable. Education:
      • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience. If you are ready to join Parexel's Journey, please apply! More...

            

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