CRA II/ Senior CRA - Italy
A leading biopharmaceutical company is currently looking to hire a CRA II/ Senior CRA to be based at their site in Italy. The company employs over 10,000 professionals and is focused on the development of innovative new therapies to improve the world's health.
- Acting as the company's sole contact with assigned clinical sites.
- Using your trial management expertise to oversee the overall integrity of the study and problem-solving skills to promote positive working relationships with the site and staff.
- Conducting qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites; generate visit/contact report.
- Reviewing the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are protected and are in accordance with the protocol.
- Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability.
- Developing 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).
- Monitoring completeness and quality of Regulatory Documentation and perform site document verification.
Skills and Requirements:
- Educated to degree level (biological science, pharmacy or other health-related discipline).
- Site Management experience or equivalent experience in clinical research, with an understanding of clinical trials methodology and terminology.
- 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.
- Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply an understanding of study protocol(s).
- 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Valeria Cardo at 0203 854 0674 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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