Senior CRA

<h2>Overview</h2> <p>ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.</p> <p> </p> <p>With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.</p> <p> </p> <p>Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.</p> <h2>Responsibilities</h2> <p><strong>The role:</strong></p> <p> </p> <p>* Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team * Acts as primary local company contact for assigned sites for specific trials.* Attends/participates in investigator meetings as needed.* Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.* Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases. * Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.* Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.* Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.* Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).* May be assigned as a coach and mentor to a less experienced site manager.* May contribute to process improvement and training.* Leads and/or participates in special initiatives as assigned.* May assume additional responsibilities or special initiatives such as “Champion” or Therapeutic Area Expert.</p> <h2>Qualifications</h2> <p><strong>To be successful in the role, you will have:</strong></p> <p> </p> <p>* A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. * Minimum 4 years of clinical trial monitoring experience is mandatory. * Must have experience in Clinical Research or equivalent qualification* Specific therapeutic area experience may be required depending on the position.* Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.* Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home. * Proficient in speaking and writing the country language and English. * Good written and oral communication skills.</p> <p> </p> <p> </p> <p> </p> <p><strong>What ICON can offer you:</strong></p> <p> </p> <p>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, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others</li> </ul> <p>Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion &amp; belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender ident