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Senior Clinical Research Associate

hace 3 meses

Alcobendas, Madrid, España Parexel A tiempo completo

At Parexel, we believe in the power of shared values to drive success.

Parexel is dedicated to enhancing global health by offering a comprehensive range of biopharmaceutical services that assist clients worldwide in translating scientific innovations into effective treatments. Our capabilities span clinical trials, regulatory affairs, consulting, and market access, all supported by a strong commitment to our core values: Patients First, Quality, Respect, Empowerment & Accountability.

Position Overview

We are seeking a Senior Clinical Research Associate to become a vital part of our Clinical Operations Team in Spain. Candidates should be located in the Madrid or Barcelona regions, with options for office or remote work.

Your Role

As a Senior Clinical Research Associate at Parexel, you will have the opportunity to exceed the expectations of a conventional clinical monitor. You will be responsible for leveraging your expertise to cultivate and sustain relationships with clinical sites, ensuring they are equipped for success. Acting as the primary liaison for clinical sites, you will address and resolve inquiries and challenges while overseeing site quality and performance from initiation to close-out.

Parexel provides cutting-edge technology and tailored training based on your individual experience. You can expect reduced travel requirements and a manageable protocol load compared to industry standards. Your dedication may be recognized through a bonus incentive program, opportunities to work across various therapeutic areas, and pathways for career advancement in clinical research. If you value impact, flexibility, and professional growth, Parexel could be the ideal environment for you.

Key Responsibilities

Utilize your expertise to conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at designated clinical sites, producing comprehensive visit/contact reports. Foster relationships by ensuring the integrity of the study and employing problem-solving skills to build rapport with site personnel. Safeguard patients by reviewing trial performance at assigned sites, ensuring the rights and well-being of human subjects are protected in accordance with the protocol. Enhance productivity by developing patient recruitment strategies in collaboration with clinical sites to meet enrollment timelines, while ensuring adherence to approved standard operating procedures (SOPs), protocols, GCP, and applicable regulatory requirements. Maintain quality by assessing the integrity of reported data, site efficacy, and drug accountability. Execute monitoring of regulatory documentation completeness and perform verification of site documents.

Qualifications

On your first day, we expect you to possess:

Experience in Site Management or a related field in clinical research, with a solid understanding of clinical trial methodologies and terminology. Capability to independently conduct all clinical monitoring activities. A Bachelor's degree or equivalent in biological sciences, pharmacy, or a related health discipline. Strong interpersonal, written, and verbal communication skills within a collaborative team environment. Experience working autonomously, demonstrating a sense of urgency and minimal oversight. A client-focused mindset and a flexible approach to assignments and learning opportunities. The ability to manage multiple tasks, assess a variety of unpredictable scenarios, and meet project timelines while applying knowledge of study protocols. An ethical and honest work ethic to support the development of transformative treatments for patients. Proficiency in computer skills, including familiarity with Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office applications such as Excel and Word.