Senior Clinical Research Monitor

hace 4 semanas

Alcobendas, Madrid, España Parexel A tiempo completo

When our values align, there's no limit to what we can achieve.

Parexel is dedicated to enhancing global health. We achieve this by offering a comprehensive range of biopharmaceutical services that assist clients worldwide in transforming scientific breakthroughs into innovative therapies. Our capabilities in clinical trials, regulatory affairs, consulting, and market access are supported by a strong commitment to our core values: Patients First, Quality, Respect, Empowerment & Accountability.

Position Overview

We are currently seeking a Clinical Research Associate II to enhance our Clinical Operations Team. Candidates should be located in the Madrid or Barcelona regions, with options for office or remote work.

Your Role

At Parexel, the role of a Clinical Research Associate provides the chance to exceed the expectations of a conventional clinical monitor. CRAs are responsible for leveraging their expertise to cultivate and sustain relationships with clinical sites, ensuring they are optimally prepared for success. As the primary liaison for clinical sites, this role involves addressing and resolving site-related inquiries and challenges. You will oversee site quality and performance from initial identification through to study closure.

Parexel offers you access to cutting-edge technology and tailored training that aligns with your experience. Expect reduced travel 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 your ideal workplace.

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 detailed visit reports. Foster relationships by ensuring the integrity of the study and employing problem-solving skills to build rapport with site personnel. Safeguard patient welfare by evaluating trial performance at designated sites, ensuring the rights and well-being of participants are protected in accordance with the study protocol. Enhance productivity by developing patient recruitment strategies in collaboration with clinical sites to meet enrollment goals, while ensuring adherence to approved standard operating procedures (SOPs), protocols, Good Clinical Practice (GCP), and relevant regulatory requirements. Ensure quality by assessing the accuracy and integrity of reported data, site efficacy, and drug accountability. Execute monitoring of regulatory documentation completeness and perform verification of site documents.

Candidate Profile

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 perform 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 adaptability regarding tasks and new learning opportunities. The ability to manage multiple responsibilities, assess various unpredictable scenarios, and meet project timelines while applying knowledge of study protocols. An ethical and honest work approach 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.

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