Senior Clinical Research Associate at PSI CRO

United States

<h3>Company Description</h3><p>We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals.  We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them.</p><p>If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.</p><h3>Job Description</h3><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.  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><u>Office-Based or Home-based</u></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><h3>Qualifications</h3><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 trials required; experience with radiopharmaceuticals and/or breast cancer preferred</li><li>Experience monitoring GI studies (IBD, Chron's, UC) is preferred. </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><h3>Additional Information</h3><p>Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid 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>