Senior Clinical Research Associate

Job description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability. We are currently seeking an experienced Clinical Research Associate (Level II or Senior) to join our Multi-Sponsor Clinical Trials Team in Romania. In this role, you will be responsible for managing study sites based in both Romania and Moldova. Your time here At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You’ll also manage site quality and delivery from site identification through to close-out. As a CRA, Parexel will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work may 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, Parexel could be your next home. What you’ll do Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports. Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff. Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol. Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s). Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability. Execute. Monitor the completeness and quality of Regulatory Documentation and perform site document verification. More about you On your first day we’ll expect you to have: Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology. Ability to perform all clinical monitoring activities independently. Experience with Oncology trials Phase I study experience Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline. Strong interpersonal, written, and verbal communication skills within a matrixed team. Experience working in a self-driven capacity, with a sense of urgency and limited oversight. A client-focused approach to work and flexible attitude with respect to assignments/new learning. The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s). An honest and ethical work approach 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. If you are ready to join Parexel’s Journey, please apply!