CRA - Germany - Single Sponsor

📋 Description

• • Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is seeking an experienced Clinical Research Associate (CRA) for a single-sponsor partnership opportunity in Germany.
• • This role is pivotal in ensuring the successful execution of clinical trials by performing comprehensive site monitoring activities, adhering strictly to regulatory standards, ICH-GCP, and Good Pharmacoepidemiology Practice (GPP) guidelines.
• • You will be responsible for conducting site qualification, initiation, interim monitoring, site management, and close-out visits, utilizing both on-site and remote methodologies to ensure data integrity and patient safety.
• • A key aspect of this role involves exercising sound judgment and experience to evaluate the overall performance of clinical trial sites and their staff, providing actionable recommendations and immediately escalating any serious issues to the project team for prompt resolution.
• • You will maintain a thorough understanding of ICH/GCP Guidelines, relevant national and international regulations, and internal company Standard Operating Procedures (SOPs) and processes, ensuring continuous compliance.
• • A critical responsibility is verifying that the informed consent process has been adequately performed and documented for each subject, demonstrating diligence in protecting patient confidentiality at all times.
• • You will assess potential risks to subject safety and clinical data integrity at investigator sites, including identifying and managing protocol deviations/violations and pharmacovigilance issues.
• • In line with the Clinical Monitoring/Site Management Plan (CMP/SMP), you will meticulously assess site processes and conduct Source Document Reviews (SDR) of relevant medical records to ensure accuracy and completeness of clinical data entered into Case Report Forms (CRFs).
• • You will apply effective query resolution techniques, both remotely and on-site, guiding site staff to ensure queries are resolved within agreed-upon timelines and utilizing available technology to support efficient data review and capture.
• • Verification of site compliance with electronic data capture requirements is essential for maintaining data quality.
• • The role may involve managing investigational product (IP) inventory, reconciliation, and overseeing its storage and security, ensuring it is dispensed and administered to subjects according to the protocol.
• • You will also verify any issues or risks associated with blinded or randomized IP information, applying your knowledge of GCP/local regulations to ensure proper handling, labeling, import, release, and return of the IP.
• • Maintaining the Investigator Site File (ISF) for accuracy, timeliness, and completeness is a core duty, including reconciling its contents with the Trial Master File (TMF) and ensuring the investigator site understands archiving requirements.
• • You will meticulously document all activities through confirmation letters, follow-up letters, trip reports, and communication logs, adhering to SOPs and the CMP/SMP.
• • Supporting subject recruitment, retention, and awareness strategies will be part of your contribution to trial success.
• • Entering data into tracking systems to monitor observations, ongoing status, and action item resolution is required to maintain project visibility.
• • You will manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met, demonstrating adaptability to changing priorities and a commitment to achieving targets.
• • The CRA may serve as the primary liaison with study site personnel, collaborating with Central Monitoring Associates as needed, and ensuring all assigned sites and project-specific team members receive appropriate training and remain compliant.
• • Active participation in Investigator Meetings, sponsor face-to-face meetings, global clinical monitoring/project staff meetings, and project-specific training sessions is expected.
• • You will contribute to audit readiness by providing guidance at the site and project level and supporting audit preparation and follow-up actions.
• • This role requires a proactive approach to problem-solving and a commitment to continuous learning and professional development within the dynamic field of clinical research.
• • By joining Syneos Health, you become part of a global team dedicated to accelerating the delivery of therapies and improving patient lives, working in a collaborative and innovative environment.
• • You will be part of a company that values its employees, fostering a culture of authenticity, diversity, and inclusion, where everyone feels they belong.
• • This position is for a potential upcoming opportunity, and expressing interest will add you to our talent pipeline for consideration.
• • You will contribute to Syneos Health's impressive track record, having worked with a significant percentage of Novel FDA Approved Drugs and EMA Authorized Products.
• • Embrace the opportunity to challenge the status quo and innovate in a highly competitive and ever-changing environment.