Job Description Senior Clinical Research Associate (Remote, Germany) Company Overview We are a globally-focused, mid-sized organization specializing in clinical research. Partnering with biotechnology and pharmaceutical companies, we provide end-to-end support across the clinical development lifecycle. Our offerings include full-service capabilities, operational resourcing, and tailored functional service solutions. Role Summary As part of our Clinical Operations team, you will collaborate with passionate professionals to support clinical trial delivery. In this role, you will be responsible for initiating, monitoring, and closing out study sites, ensuring compliance with protocols, regulatory standards, and organizational policies. Key Responsibilities Site Monitoring and Compliance Conduct on-site and remote monitoring visits in alignment with GCP, ICH guidelines, and regulatory requirements. Ensure participant safety through oversight of informed consent processes and protocol adherence. Verify accuracy of clinical trial data by comparing Case Report Forms (CRFs) to source documents. Manage investigational product accountability, ensuring proper storage and use compliance. Documentation and Reporting Prepare comprehensive monitoring visit reports, including corrective/preventive actions. Maintain site documents in the Trial Master File (TMF) and ensure the Investigator Site File (ISF) meets compliance standards. Update Clinical Trial Management Systems (CTMS) and other platforms with accurate site-level data. Issue Resolution and Collaboration Communicate site-specific action items to staff and ensure timely resolution of any issues identified. Participate in audits, inspections, and associated follow-up activities. Qualifications Education and Experience Bachelor’s degree in life sciences, nursing, or equivalent field. Over 5 years of experience as a Clinical Research Associate, including significant site monitoring expertise. Familiarity with medical terminology and the science underlying therapeutic areas. Skills and Knowledge Strong understanding of GCP, ICH, and regulatory guidelines. Proficiency in clinical trial software systems and tools. Exceptional organizational, analytical, and written/verbal communication skills. Fluency in English and German is required. Personal Attributes Flexible, proactive, and solutions-oriented mindset. Strong ownership and accountability for assigned tasks. Ability to manage complex or early-phase studies independently. Collaborative, with excellent conflict resolution and discussion facilitation skills. Travel Requirements Willingness to travel up to 60–80%, including overnight and international trips, as needed. LI-OG1