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<p><span> </span><b><span class="emphasis-2">Job Overview:</span></b></p><ul><li><p>Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks to include receiving and logging-in and scanning contractual and validation documentation. Assist project teams with validation tasks as requested, i.e., with the creation, production, printing and tracking of study documentation and controlled documents.</p></li></ul><p></p><p></p><p><b><span class="emphasis-2">Summary of Responsibilities:</span></b></p><ul><li><p>Serves as a member of the project team with primary responsibilities for all documentation, requirements to support global EDC solutions tasks.</p></li><li><p>Assist project teams with validation tasks as requested.</p></li><li><p>Assist with creation, production, printing and tracking of study documents and other controlled documents as needed.</p></li><li><p>Create and execute validation test scripts as requested and document the test results.</p></li><li><p>Ensure quality of work.</p></li><li><p>Prioritize workload to meet specified completion dates.</p></li><li><p>Assist with the maintenance of validation metrics.</p></li><li><p>Carry out all activities according to Fortrea Standard Operation Procedures (SOPs) and project specific conventions within the framework of Quality Management and Good Clinical Practice (GCP)/ICH guidelines.</p></li><li><p>Maintain accurate records of all work performed.</p></li><li><p>Perform other duties as assigned by management.</p></li><li><p>Assist with special projects as designated.</p></li><li><p>And all other duties as needed or assigned.</p></li></ul><p></p><p><b><span class="emphasis-2">Qualifications (Minimum Required):</span></b></p><ul><li><p>University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.</p></li><li><p>Fortrea may consider relevant and equivalent experience in lieu of educational requirements.</p></li><li><p>Fluent in English, both written and verbal.</p></li></ul><p></p><p><b><span class="emphasis-2">Experience (Minimum Required):</span></b></p><ul><li><p>3 years of validation experience working with a global CRO/Pharma</p></li><li><p>A neat, methodical, and thorough approach to the work with an emphasis on attention to detail.</p></li><li><p>Good concentration skills are required to meet the consistently high standards expected.</p></li><li><p>Self-motivation with the ability to work under pressure to meet demanding deadlines.</p></li><li><p>Effective communication skills and the ability to work as part of a team.</p></li><li><p>Flexibility – being able to move from one computer system to another with ease and adapt to modern technology and a constantly changing work environment.</p></li></ul><p></p><p><b><span class="emphasis-2">Physical Demands/Work Environment:</span></b></p><ul><li><p>Home based</p></li></ul><p><span> </span></p><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank" rel="noopener noreferrer">EEO & Accommodations request here</a><span>.</span></p>