Clinical Research Associate - MEA unblinded role

<h2>Job Overview:</h2><p style="margin: 0cm; margin-bottom: .0001pt;">CRA I - MEA is an essential member of a Clinical Project Team responsible for the<br />execution of a Clinical Research Project.</p><p style="margin: 0cm; margin-bottom: .0001pt;"> </p><p style="margin: 0cm; margin-bottom: .0001pt;">The degree of responsibility given to the CRA I - MEA shall reflect their experience, and level of contribution which they can make to the project. The work will involve Operations activities which will be conducted for designated projects as well as some travel to conduct site visits or to attend client or internal team meetings as needed. The CRA I - MEA will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members. Activities will be conducted in compliance with Company or Sponsor SOPs, regulatory standards and applicable. </p><p style="margin: 0cm; margin-bottom: .0001pt;"> </p><p style="margin: 0cm; margin-bottom: .0001pt;">You may be office based if you live in Melbourne.</p><p style="margin: 0cm; margin-bottom: .0001pt;">If you are Brisbane based you should have some prior monitoring experience, ideally at least three to six months.  You may have to opportunity to be fully home based, with occasional travel to hospital sites expected.</p><h2>Education/Qualifications:</h2><p style="margin: 0px;">Minimum Required:<br />♦ External Candidates<br />o University or college degree, or certification in a related allied health profession from<br />an appropriately accredited institution (e.g., nursing licensure)<br />AND<br />o A minimum of 2 years of experience in a related role (e.g. site management, in-house<br />CRA, study coordinator, research nurse, etc.)<br />♦ Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory<br />requirements<br />♦ Basic understanding of the clinical trial process<br />♦ Valid Driver’s License<br />Preferred:<br />♦ Working knowledge of Covance SOPs for site monitoring</p><h2>Experience:</h2><p style="margin: 0px;">Minimum Required:<br />o University or college degree, or certification in a related allied health profession<br />from an appropriately accredited institution (e.g., nursing licensure)<br />AND<br />o a minimum of 2 years e of industry experience in a related role (e.g. site management,<br />in-house CRA, study coordinator, research nurse, etc.)<br />♦ Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH<br />Guidelines and GCP<br />♦ Ability to work within a project team<br />♦ Good planning, organization and problem solving abilities<br />♦ Good communication skills, oral and written<br />♦ Good computer skills<br />♦ Works efficiently and effectively in a matrix environment<br />♦ Fluent in local office language and in English, both written and verbal<br />Draft: Dec 2020 Page 6 of 7<br />Preferred:<br />♦ One (1) or more additional years of experience in a related field (i.e., medical, clinical,<br />pharmaceutical laboratory, research, data analysis, data management or technical writing) is<br />preferred.</p>