CRA/Senior CRA

<h2>Overview</h2> <p>As a CRA you will be joining the world’s largest &amp; most comprehensive clinical research organisation, powered by healthcare intelligence.</p> <h2>Responsibilities</h2> <p><strong>What you will be doing:</strong></p> <ul> <li>Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites</li> <li>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial</li> <li>Performs clinical study site management/monitoring activities in compliance with ICH‐GCP, Sponsor SOPs, Local Laws &amp; Regulations, Protocol, Site Monitoring Plan and associated documents</li> <li>Gains an in‐depth understanding of the study protocol and related procedures</li> <li>Coordinates &amp; manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</li> <li>Participates &amp; provides input on site selection and validation activities</li> <li>Performs remote and on‐site monitoring &amp; oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased; subjects’ right, safety and well‐being are protected</li> <li>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close‐out visits and records clear, comprehensive and accurate visit &amp; non‐visit contact reports appropriately in a timely manner</li> <li>Collects, reviews, and monitors required regulatory documentation for study start‐up, study maintenance and study close‐out</li> <li>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance</li> <li>Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites</li> <li>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelinesSupports and/or leads audit/inspection activities as needed</li> <li>Performs co‐monitoring as appropriate</li> </ul> <h2>Qualifications</h2> <p><strong>You are:</strong></p> <ul> <li>B.A./B.S. preferred with strong emphasis in science and/or biology</li> <li><p>Min. 1 year of direct monitoring experience</p></li> <li><p>Previous experience in oncology trials or ready to monitor oncology trials will be an asset </p></li> <li>Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively</li> <li>Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH &amp; country clinical research law &amp; guidelines</li> <li>Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.</li> <li>Demonstrated ability to mentor/lead</li> <li>Hands on knowledge of Good Documentation Practices</li> <li>Proven Skills in Site Management including independent management of site performance and patient recruitment</li> <li>Demonstrated high level of monitoring skill with independent professional judgment</li> <li>Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices</li> <li>Ability to understand and analyze data/metrics and act appropriately</li> <li>Experience with conducting site motivational visit designed to boost site enrollment</li> <li>Capable of managing complex issues, working solution-oriented</li> <li>Performs root cause analysis and implements preventative and corrective action</li> </ul> <p><strong>What ICON can offer you:</strong>Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:</p> <ul> <li>Various annual leave entitlements</li> <li>A range of health insurance offerings to suit you and your family’s needs</li> <li>Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead</li> <li>Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being</li> <li>Life assurance</li> <li>Flexible country-specific optional benefits, i