Clinical Research Associate Ii

2 semanas atrás

São Paulo, Brasil buscojobs Brasil Tempo inteiro

When our values align, there's no limit to what we can achieve.

In Parexel, we are looking for an experienced CRA to make onsite monitoring visits in Brazil. Oncology experience is required.

Your time here

At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRAs are accountable for using their expertise to build and maintain site relationships and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You’ll also manage site quality and delivery from site identification through to close-out.

As a CRA, Parexel will offer you world-class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work may be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas, and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, Parexel could be your next home.

What you’ll do

  1. Leverage your expertise: Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
  2. Build relationships: Oversee the integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
  3. Protect patients: Review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are safeguarded and are in accordance with the protocol.
  4. Drive productivity: Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
  5. Ensure quality: Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability.
  6. Execute: Monitor the completeness and quality of Regulatory Documentation and perform site document verification.

More about you

On your first day, we’ll expect you to have:

  • Site Management or equivalent experience in clinical research, with an understanding of clinical trials methodology and terminology.
  • Experience working in Oncology Trials.
  • Ability to perform all clinical monitoring activities independently.
  • Bachelor’s or equivalent degree in biological science, pharmacy, or other health-related discipline.
  • Strong interpersonal, written, and verbal communication skills within a matrixed team.
  • Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
  • A client-focused approach to work and flexible attitude with respect to assignments/new learning.
  • The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios, and achieve project timelines while being able to apply your understanding of study protocol(s).
  • An honest and ethical work approach to promote the development of life-changing treatments for patients.
  • Strong computer skills, including but not limited to knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
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