Senior Clinical Research Associate Contractor, Switzerland

<div class="content-intro"><p><strong>We are Growing</strong>! Let us support your career journey the Biorasi way.  Innovative, Collaborative, Dynamic and Evolving.  Capitalizing on your strengths while encouraging work-life balance.  Biorasi is an award-winning, customer-focused, full-service clinical research organization.</p> <p>Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.</p></div><p><strong>Your role:</strong></p> <ul> <li>Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.</li> <li>Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.</li> <li>Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution</li> <li>Provide project updates to project management team.</li> <li>Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.</li> <li>Perform investigational product inventory and ensure return of unused investigational product to designated location or verify destruction as required.</li> <li>Assists with, prepare for, and attends Investigator Meetings for assigned studies.</li> <li>Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate issues at site to project management.</li> <li>Collect and review essential study documents from site for filing in eTMF.</li> <li>Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.</li> <li>Evaluates quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.</li> <li>Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.</li> <li>Assists the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing