Senior Clinical Research Associate
il y a 2 jours
PAREXEL has launched a new clinical operating model to drive effectiveness, reduce hand-offs and increase employee, client and site satisfaction. Within this model, the Clinical Research Associate (CRA), serves as the clinical sites’ direct point of contact. 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 the site relationship and ensure they are set up for success. This includes addressing and resolving site issues and questions. You will also manage site quality and delivery from site identification through to close-out.
**This role can be office-based in Waver or decentralised.**
**Your Key Accountabilities**:
Act as PAREXEL’s sole contact with assigned clinical sites
Use your trial management expertise to oversee overall integrity of the study and problem-solving skills to promote positive working relationships with the site and staff
Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites; generate visit/contact report
Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability
Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines Ensure compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s)
Monitor completeness and quality of Regulatory Documentation and perform site document verification
**Your Skillset**:
Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Educated to degree level (biological science, pharmacy or other health related discipline)
Fluency in the Dutch, French and English languages
Demonstrates strong interpersonal, written, and verbal communication skills within a matrixed team
Ability to work in a self-driven capacity, with a sense of urgency and limited need for oversight
Client focused approach to work; flexible attitude with respect to work assignments and new learning
Work ethically and honestly to promote the development of life changing treatments for patients
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 the Dutch, French and English languages is required.
**Our Offer**:
Join the best minds in the industry and leverage your expertise to help advance treatments into the hands of those who need them most. This role is an excellent opportunity to enhance your skills and take the lead on client projects.
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