CRA I - single sponsor - Eastern Germany (Leipzig)

📋 Description

• • As a Clinical Research Associate (CRA) I at Syneos Health, you will play a pivotal role in ensuring the successful execution of clinical trials by meticulously monitoring investigational sites across Eastern Germany, with a specific focus on Leipzig. This position is dedicated to a single sponsor, offering a focused and impactful experience within a dynamic biopharmaceutical solutions organization.
• • Your primary responsibility will be to conduct comprehensive site qualification, initiation, interim monitoring, site management, and close-out visits. These activities will be performed both on-site and remotely, demanding adaptability and a keen eye for detail to ensure strict adherence to regulatory standards, ICH-GCP (International Council for Harmonisation of Good Clinical Practice), GPP (Good Pharmacoepidemiology Practice), and the specific study protocol.
• • You will utilize your professional judgment and experience to evaluate the overall performance of clinical sites and their staff. This includes identifying potential risks, assessing compliance, and providing actionable recommendations for site-specific improvements. Immediate communication and escalation of serious issues to the project team, followed by the development of robust action plans, will be crucial for maintaining trial integrity.
• • A fundamental aspect of your role involves maintaining a thorough understanding of ICH/GCP Guidelines, relevant national and international regulations, and Syneos Health’s Standard Operating Procedures (SOPs) and internal processes. Continuous learning and staying abreast of evolving regulatory landscapes are essential.
• • You will meticulously verify that the informed consent process has been adequately performed and documented for each study participant, demonstrating a strong commitment to protecting subject confidentiality and rights. Assessing factors that could impact subject safety and the integrity of clinical data, such as protocol deviations, violations, and pharmacovigilance issues, will be a daily task.
• • In alignment with the Clinical Monitoring/Site Management Plan (CMP/SMP), you will assess site processes, conduct thorough Source Document Reviews (SDR) of medical records, and verify the accuracy and completeness of clinical data entered into Case Report Forms (CRFs). You will be adept at applying query resolution techniques both remotely and on-site, guiding site staff to ensure queries are resolved efficiently and within agreed timelines.
• • The role requires proficiency in utilizing available hardware and software to support effective clinical study data review and capture, including verifying site compliance with electronic data capture (EDC) requirements. This technological aptitude ensures seamless data flow and integrity.
• • You may also be responsible for investigational product (IP) inventory, reconciliation, and ensuring its proper storage and security. Verifying that IP has been dispensed and administered to participants according to the protocol, and addressing any issues or risks associated with blinded or randomized information, will be part of your duties. Your knowledge of GCP/local regulations will ensure IP is appropriately handled, including labeling, import, and return processes.
• • Maintaining the Investigator Site File (ISF) for accuracy, timeliness, and completeness is a key responsibility. You will reconcile ISF contents with the Trial Master File (TMF) and ensure investigators are aware of essential document archiving requirements in accordance with local guidelines and regulations.
• • Documentation is critical. You will meticulously document all activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents, adhering strictly to SOPs and the CMP/SMP. You will also actively support subject recruitment, retention, and awareness strategies, contributing to the overall success of the trial.
• • Data entry into tracking systems to monitor observations, track ongoing status, and manage action items to resolution will be a regular task, ensuring transparency and accountability.
• • You will manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met, demonstrating an ability to adapt quickly to changing priorities in a fast-paced environment.
• • Acting as the primary liaison with study site personnel, and potentially collaborating with Central Monitoring Associates, you will ensure all assigned sites and project-specific site team members are adequately trained and compliant with all applicable requirements.
• • You will prepare for and attend Investigator Meetings and sponsor face-to-face meetings, as well as participate in global clinical monitoring/project staff meetings, including sponsor representation when applicable. Continuous engagement in clinical training sessions tailored to project-specific requirements is expected.
• • Providing guidance at both the site and project level towards audit readiness standards and supporting preparation for audits, including managing required follow-up actions, will be essential for maintaining high-quality trial conduct.
• • This role offers a unique opportunity to contribute significantly to the acceleration of life-changing therapies by ensuring the highest standards of clinical trial conduct are met. You will be an integral part of a global team dedicated to improving patient outcomes and driving innovation in the biopharmaceutical industry.