Senior Clinical Research Associate

📋 Description

• • As a Senior Clinical Research Associate (SCRA) at BeiGene, Ltd., you will play a pivotal role in ensuring the quality, integrity, and patient safety of our groundbreaking clinical trials. This remote position within the US offers a unique opportunity to contribute to our mission of fighting cancer by managing and overseeing assigned clinical study sites. You will be instrumental in upholding the highest standards of Good Clinical Practice (GCP) guidelines, local regulations, and internal Standard Operating Procedures (SOPs), ensuring that every aspect of the trial is conducted with precision and care.
• • Your primary responsibility will be the meticulous monitoring of clinical study sites. This involves conducting comprehensive site visits to assess protocol compliance, regulatory adherence, and the overall safety and efficacy of investigational products or medical devices. You will be the key liaison between BeiGene and the investigative sites, fostering strong, collaborative relationships with site staff and study vendors to facilitate smooth trial operations.
• • A critical component of your role will be to proactively track enrollment status reports, working closely with sites to ensure they remain on track to meet ambitious enrollment goals. You will also meticulously monitor study-specific status reports, ensuring that all required information regarding site issues, deviations, and Case Report Form (CRF) status is kept current and accurate by the monitoring team. This vigilance is crucial for identifying potential roadblocks early and implementing timely solutions.
• • As a senior member of the team, you will serve as a vital mentor and trainer for less experienced CRAs. You will provide guidance on general and study-specific monitoring issues, sharing your expertise to foster the development of the entire CRA team. This mentorship extends to providing direct support to the Clinical Study Manager, assisting with the review of monitoring visit reports and undertaking other managerial tasks as needed, thereby contributing to the overall efficiency of the Clinical Study Team (CST).
• • You will be involved in developing and delivering study-specific training to project teams, ensuring everyone involved in the trial has a thorough understanding of the protocol and their responsibilities. Furthermore, you will contribute to the creation of study-specific monitoring tools and forms, designed to enhance the efficiency and effectiveness of the monitoring team's review of study data. This proactive approach to process improvement is highly valued at BeiGene.
• • A significant responsibility includes performing Serious Adverse Event (SAE) reconciliation, working collaboratively with study sites and CRAs to resolve any discrepancies promptly. You will also review outstanding data reports and partner with CRAs to ensure data collection meets contractual guidelines, maintaining the integrity of the clinical data.
• • You will collaborate closely with Clinical Trial Oversight Managers (CTOMs) and the CST to manage site trends through dashboard reviews and ongoing risk assessments. This involves identifying potential quality standards issues and addressing concerns related to study delivery at sites, all within established protocols and under general supervision. Your insights will be crucial in maintaining the highest quality standards across all monitored sites.
• • Ensuring the timely delivery of study milestones, from startup and recruitment to database analysis and closeout, will be a key focus. You will work with the CST and clinical study sites to achieve these critical objectives. Additionally, you will provide essential support to study sites and CRAs in preparing for and responding to audits and inspections, as well as addressing quality issues. You will follow through on audit/inspection findings to ensure resolution, particularly as they relate to the involved CRA staff.
• • You will assist with other assigned clinical responsibilities within the scope of the role, contributing to best practices and offering support to junior clinical staff. Your proactive engagement and commitment to continuous improvement will be instrumental in optimizing the effectiveness and efficiencies within the Site Management group and the broader Americas region.
• • This role requires a strong command of industry-standard CTMS and data management systems, alongside proficiency in Microsoft Word, Excel, PowerPoint, and Outlook. Your understanding of clinical trial processes, coupled with a thorough knowledge of ICH and associated regulatory guidelines, will be essential for success. The position involves travel up to 40-60% of the time, requiring flexibility and a willingness to engage with sites across various locations.