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SENIOR CLINICAL RESEARCH ASSOCIATE

Psicro
Full-timesenior

Job description

<p>As a Senior Clinical Research Associate 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.&#xa0; You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.</p><p>You will:</p><ul><li>Conduct and report all types of onsite monitoring visits</li><li>Be involved in study startup (if applicable)</li><li>Perform CRF review, source document verification and query resolution</li><li>Be responsible for site communication and management</li><li>Supervise study activities, timelines, and schedules on the country level</li><li>Be a point of contact for in-house support services and vendors</li><li>Be involved in quality control, such as compliance monitoring and reports review</li><li>Participate in feasibility research</li><li>Support regulatory team in preparing documents for study submissions</li></ul> <ul><li>College/University degree in Life Sciences or an equivalent combination of education, training &amp; experience</li><li>Independent on-site monitoring experience in the USA (5 years minimum)</li><li>Experience in all types of monitoring visits in Phase I-III</li><li>Participation in clinical projects as a Senior Monitor</li><li>Experience monitoring complex Oncology&#xa0;trials required; experience with radiopharmaceuticals and/or breast cancer preferred</li><li>Experience monitoring GI studies (IBD, Chron's, UC) is preferred.&#xa0;</li><li>Full working proficiency in English</li><li>Proficiency in MS Office applications</li><li>Ability to plan, multitask and work in a dynamic team environment</li><li>Communication, collaboration, and problem-solving skills</li><li>Ability to travel up to 80%</li><li>Valid driver’s license (if applicable)</li></ul><p><strong><em>For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.</em></strong></p> <p>Advance your career in clinical research and lead challenging full-service projects on the country/regional level&#xa0;while growing with a rapid&#xa0;company, that puts its people first! You will get hands-on involvement in every aspect of the study.</p><p>For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.</p>

Skills

MS Office