Senior Clinical Research Associate II

<p></p> <p><span><span><strong><span>Job Title:            </span> <span>Senior Clinical Research Associate II</span></strong></span></span></p> <p><span><span><strong>Job Location:</strong>    <span>France (Home-based position, any location in France considered)</span></span></span></p> <p><span><span><b>Job Overview:   </b></span></span></p> <p><span><span>The Senior Clinical Research Associate II monitors investigational sites to ensure subject safety and provide high quality data review and reporting in compliance with the Caidya and/or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, ISO14155, and other applicable regulations. Builds, manages and supports strong site relationships while serving as liaison between the Sponsor and assigned sites.</span></span></p> <p> </p> <p><span><span><b>Job Duties and Responsibilities:</b></span></span></p> <ul> <li><span><span>Provides support to Project Team and Clinical Operations Team.</span></span></li> <li><span><span>Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects.</span></span></li> <li><span><span>Demonstrates strong written and verbal communication skills.</span></span></li> <li><span><span>Serves as primary contact for assigned research sites. </span></span></li> <li><span><span>Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.</span></span></li> <li><span><span>Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.</span></span></li> <li><span><span>Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.</span></span></li> <li><span><span>Verifies the rights and well-being of trial subjects are protected.</span></span></li> <li><span><span>Reconciles site regulatory binder assuring collection and completeness of regulatory documents.</span></span></li> <li><span><span>Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.</span></span></li> <li><span><span>May support translations of essential documents.</span></span></li> <li><span><span>May support submission of trials to IRB/IEC and regulatory authorities.</span></span></li> <li><span><span>Verifies that written informed consent was obtained before each subject’s participation in the trial.</span></span></li> <li><span><span>Verifies that the investigator is enrolling only eligible subjects.</span></span></li> <li><span><span>Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan.  Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.</span></span></li> <li><span><span>Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.</span></span></li> <li><span><span>Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.</span></span></li> <li><span><span>Verifies and supports the recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.</span></span></li> <li><span><span>Ensures that sites have sufficient project specific supplies. </span></span></li> <li><span><span>Manages investigative sites in respect to the trial conduct and motivates sites to meet study goals.</span></span></li> <li><span><span>Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.</span></span></li> <li><span><span>Delivers high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans. </span></span></li> <li><span><span>Participates in site audits, as requested.</span></span></li> <li><span><span>May conduct site and study feasibility assessments.</span></span></li> <li><span><span>Provides input into study documentation and monitoring worksheets.</span></span></li> <li><span><span>Uphold the confidentiality agreements with all clients and colleagues outside Caidya Clinical Research.</span></span></li> <li><span><span>Pays attention to signals of fraud, misconduct and escalates per Caidya SOP.</span></span></li> <li><span><span>Work according to the Caidya Quality Management System and actively participate in giving feedback and suggesting improvements to current processes.</span></span></li> <li><span><span>Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accuratel