Clinical Trial Specialist - Remote - FSP

📋 Description

• • Embark on a rewarding career journey with Parexel International Corporation, a global leader dedicated to improving patient well-being through innovative clinical development solutions. We are actively seeking a highly motivated and experienced Clinical Trial Specialist to join our FSP (Functional Service Provider) team, supporting one of our key sponsors. This remote position offers a unique opportunity to contribute significantly to the advancement of life-changing therapies across diverse therapeutic areas.
• • As a Clinical Trial Specialist, you will play a pivotal role in providing essential technical and administrative support to clinical study teams, ensuring the seamless and compliant execution of clinical trials. Your contributions will directly impact the successful progression of studies from initiation to close-out, adhering to the highest standards of quality and regulatory compliance.
• • You will collaborate closely with the Clinical Trial Manager and other study team members, offering comprehensive support for moderately complex clinical study activities. This includes ensuring all trial activities are meticulously conducted in accordance with Good Clinical Practice (GCP) guidelines and relevant Standard Operating Procedures (SOPs), maintaining the integrity and reliability of study data.
• • A key aspect of your role will involve assisting with vendor oversight and management, working under guidance to ensure third-party services meet project requirements and timelines. You will develop a keen eye for identifying potential issues and risks within study execution, proactively escalating them to management for timely resolution and mitigation.
• • You will be entrusted with the oversight of the Trial Master File (TMF), ensuring its completeness, accuracy, and adherence to regulatory requirements. This critical function guarantees that all essential trial documentation is properly maintained and accessible, forming the backbone of study compliance.
• • Depending on the needs of the study, you may also be involved in the review of monitoring visit reports, contributing to the quality assurance of site activities. In some instances, you might participate in co-monitoring visits or provide oversight of monitoring activities, further ensuring the effective implementation of study protocols at clinical sites.
• • This role demands a proactive and detail-oriented approach, with a strong emphasis on collaboration and communication. You will be instrumental in fostering a positive and efficient working environment for the study team, contributing to the overall success of clinical research initiatives.
• • Parexel's commitment to improving the world's health is deeply ingrained in our culture. We support clinical studies across a vast spectrum of therapeutic areas and have established enduring partnerships with a wide array of clients. Our impact is significant, having supported the trials of many of today's top-selling drugs, while also championing the development of niche therapies crucial for patient well-being.
• • You will become an influential member of a dynamic and supportive wider team, where your expertise and dedication will be valued. We seek professionals who possess the determination and courage to consistently prioritize patient well-being, embodying our core value of 'working with heart'.
• • This position offers the flexibility of remote work, allowing you to contribute effectively from your chosen location. While the role is primarily remote, occasional travel (10-20%) may be required for specific study-related activities, such as co-monitoring or oversight visits, ensuring comprehensive engagement with clinical trial sites.
• • By joining Parexel, you are not just taking on a job; you are becoming part of a mission-driven organization that makes a tangible difference in the lives of patients worldwide. We offer a challenging yet rewarding environment where your skills and passion for clinical research can flourish.