Initiation Clinical Research Associate I

1 week ago

King of Prussia, United States PAREXEL Full time

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

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