Clinical Research Associate II at PSI CRO

United States

<h3>Company Description</h3><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><h3>Job Description</h3><p>As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.</p><p>You will:</p><ul><li>Act as the main line of communication between the project team, sponsor, and the site</li><li>Build and maintain a good relationship with the site staff involved in the study conduct</li><li>Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits</li><li>Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level</li><li>Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations</li><li>Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level</li><li>Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites</li><li>Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level</li><li>Ensures quality (data integrity and compliance) at site level</li><li>Conduct site audit preparation visits and resolve site audit findings</li><li>Participate in study site audits and client onsite visits, as required</li><li>Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse</li><li>Conduct project-specific training of site investigators</li><li>Support preparation of Investigator newsletters</li><li>Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level</li><li>Support preparation of draft regulatory and ethics committee submission packages</li><li>Support collection of IP-RED packages at site/country level</li><li>Facilitate review and reconciliation of the study TMF on country and site levels </li></ul><h3>Qualifications</h3><ul><li>College/University degree in Life Sciences or an equivalent combination of education, training &amp; experience</li><li>Located in Central or West Coast preferred*</li><li>2+ years of independent on-site monitoring experience required</li><li>Experience in all types of monitoring visits, in phases I-III</li><li>Experience in Oncology mandatory &amp; GI preferred and/or radio-pharm experience 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 75%</li><li>Valid driver’s license (if applicable)</li></ul><p> </p><h3>Additional Information</h3><p>This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.</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>