Senior CRA - Barcelona - home based

Proclinical are recruiting for a Senior CRA to work at a leading multinational contract research organisation in Barcelona. The company boast an excellent working environment, challenging training and development programmes and exciting projects to work on. The Clinical Site Manager (CSM), formerly the Clinical Research Associate (CRA), will serve as the clinical sites' direct point of contact. The CSM role incumbent will be accountable for using their expertise to build and maintain the site relationship and ensure that they are set up for success. This includes addressing and resolving site issues and questions.

As CSM, you will be offered world class technology and training catered to your individual experience. Your hard work will 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, please apply to learn more.

Job Responsibilities:

• Acting as the company's sole contact with assigned clinical sites.
• Using 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.
• Conducting qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites; generating visit/contact reports.
• 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 protocol.
• Evaluating 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 enrolment timelines, whilst ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirements (s).
• Monitoring completeness and quality of Regulatory Documentation, and performing site document verification.

Skills and Requirements:

• At least a BS/BA in a biology, 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.
• Demonstrably strong interpersonal, written, and verbal communication skills within a matrixed team
• Client focused approach to work; flexible attitude with respect to work assignments and new learning
• Able to work independently or in a team environment.
• Good organisational and time management skills.
• Working knowledge of SOP and WPDs.
• Able to organise competing priorities logically and review outstanding contractual risk and issues.
• Able to effectively use automated systems and computerised applications, such as a Clinical Trial Management System (CTMS), Electronic Document Management Systems (EDMS) Microsoft Outlook, Excel, Word, etc.

To Apply:

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 call Theodora Savlovschi-Wicks on +44 203 752 0314 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.

#LI-63892003_TS1