Clinical Research Associate

2 weeks ago


Darwin, Northern Territory, Australia Pharmiweb Full time
About the Role

Parexel is a leading provider of biopharmaceutical services, and we're seeking a skilled Clinical Research Associate to join our Clinical Operations Team in the UK. As a CRA, you'll play a critical role in ensuring the success of our clinical trials by building and maintaining strong relationships with clinical sites, managing site quality and delivery, and addressing any issues that may arise.

Key Responsibilities
  • Conduct qualification visits, site initiation visits, monitoring visits, and termination visits at assigned clinical sites, generating visit/contact reports as needed.
  • Build and maintain strong relationships with clinical sites, promoting rapport and ensuring the integrity of the study.
  • Review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are safeguarded and in accordance with protocol.
  • Develop patient recruitment strategies in conjunction with clinical sites to meet enrollment timelines, while ensuring compliance with approved standard operating procedures, protocol/amendments, GCP, and applicable regulatory requirements.
  • Evaluate the quality and integrity of reported data, site efficacy, and drug accountability.
  • Monitor the completeness and quality of regulatory documentation and perform site document verification.
Requirements
  • Site management or equivalent experience in clinical research, with a strong understanding of clinical trials methodology and terminology.
  • 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 unpredictable scenarios, and achieve project timelines while applying 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 knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
About Parexel

Parexel is a global biopharmaceutical services company that helps clients transform scientific discoveries into new treatments. We're committed to our values of Patients First, Quality, Respect, Empowerment, and Accountability, and we're seeking like-minded individuals to join our team.



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