Senior Initiation Clinical Research Associate

hace 7 días

En remoto, España Parexel A tiempo completo
The
Initiation Clinical Research Associate (iCRA) specialises 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 I 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 startup phase.
  • Build relationships with investigators and site staff.
  • Conduct, drive and manage country specific feasibility and/or site prequalification and qualification activities, which may include:
  • Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
  • Conduct remote Qualification Visits (QVs).
  • 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.
  • 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).

Education:

  • Educated to degree level (biological science, pharmacy, or other healthrelated discipline preferred) or equivalent nursing qualification or other equivalent experience.

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

Skills:

  • Strong problemsolving skills.
  • Able to take initiative and work independently, and to proactively seek guidance when necessary.
  • Excellent presentation skills.
  • Client focused approach to work.
  • Flexible attitude with respect to work assignments and new learning.
  • 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.
  • Willingness to work in a matrix environment and to value the importance of teamwork.
  • 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.
  • Excellent interpersonal, verbal, and written communication skills.
  • Fluent command of Polish and English (written and oral) is a must.
  • Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
  • Excellent time management in order to meet study needs, team objectives, and department goals.
  • Shows commitment to and performs consistently high quality work.
  • Ability to successfully work in a ('virtual') team environment.
  • Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
  • Attention to detail.

If you are ready to join Parexel's Journey, please apply

Attachments:

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