Senior Clinical Research Associate I

<h3>Company Description</h3><p>PSI is a leading Contract Research Organisation with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.</p><h3>Job Description</h3><p>As a Senior CRA I, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.</p><p>Your responsibilities will include:</p><ul><li>Conducting and reporting all types of onsite monitoring visits</li><li>Performing CRF reviews, source document verification and query resolution</li><li>Be responsible for site communication and management</li><li>Supervising study activities, timelines, and schedules for each site</li><li>Acting as a point of contact for in-house support services and vendors</li><li>Supporting quality control, such as compliance monitoring and reports review</li><li>Participating in feasibility research</li><li>Supporting the regulatory team in preparing documents for study submissions and regulatory approval</li><li>Driving the study startup phase (if applicable)</li></ul><h3>Qualifications</h3><ul><li>BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training &amp; experience</li><li>Independent on-site monitoring experience in the Czech Republic, ideally on multiple projects at a time</li><li>Demonstrable experience in all types of monitoring visits in Phase II and/or III</li><li>Fluency in Czech and English</li><li>Full and clean driver's license, and the ability to travel</li><li>Experience supporting Oncology studies is beneficial</li><li>Intermediate to Advanced knowledge of MS Office</li><li>Ability to plan, multitask and work in a dynamic team environment</li><li>Communication, collaboration, and problem-solving skills are essential</li></ul><h3>Additional Information</h3><p>Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.</p>