About this role
<p>As a Contract Clinical Research Associate II, 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>Home-based (freelance)</p><h3>You will:</h3><ul>
<li>Conduct and report all types of onsite monitoring visits</li>
<li>Be involved in study startup </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 & experience</li>
<li>A minimum of 1 year of independent on-site monitoring experience in Portugal</li>
<li>Experience in all types of monitoring visits in Phase II and/or III</li>
<li>Experience in IBD/Inflammatory Bowel Diseases is mandatory</li>
<li>Full working proficiency in English and Portuguese </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</li>
</ul><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><p>PSI is a leading Contract Research Organization with more than 30 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><p>Originally posted on <a href="https://himalayas.app">Himalayas</a></p>
clinical-research-associateclinical-monitoringclinical-trialspharmaceutical-researchcraclinical-research-associate-iiclinical-trials-associateclinical-trial-associate