Clinical Research Associate I

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    "timeType": "Full time",
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    "startDate": "2026-06-03",
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    "jobDescription": "<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we&#39;re committed to making a difference.</p><p></p><p></p><p><u><b>Key Accountabilities:</b></u></p><p><b>Maintenance (from initiation through close out):</b></p><p>Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.</p><ul><li><p>Build relationships with investigators and site staff.</p></li><li><p>Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.</p></li><li><p>Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions &amp; follow-up, if necessary / relevant.</p></li><li><p>Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.</p></li><li><p><span>Address/evaluate/resolve</span> issues pending from the previous visit, if any.</p></li><li><p>Follow-up on and respond to appropriate site related questions.</p></li><li><p>Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.</p></li><li><p>Actively participate in Investigator and other external or internal meetings and audits &amp; regulatory inspections as required.</p></li><li><p>Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.</p></li><li><p>Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.</p></li><li><p>Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.</p></li><li><p>Conduct remote visits/contacts as requested/needed.</p></li><li><p>Generate visit/contact report.</p></li><li><p>Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.</p></li><li><p>Assess &amp; manage test article/study supply including supply, accountability and destruction/return status.</p></li><li><p>Review &amp; follow-up site payment status.</p></li><li><p>Follow-up on CRF data entry, query status, and SAEs.</p></li><li><p>Conduct on-site study-specific training (if applicable).</p></li><li><p>Perform site facilities assessments</p></li><li><p>Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution</p></li></ul><p><u><b>Skills:</b></u></p><ul><li><p>Sound problem solving skills.</p></li><li><p>Able to take initiative and work independently, and to proactively seek guidance when necessary.</p></li><li><p>Advance presentation skills.</p></li><li><p>Client focused approach to work.</p></li><li><p>Ability to interact professionally within a client organization.</p></li><li><p>Flexible attitude with respect to work assignments and new learning.</p></li><li><p>Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.</p></li><li><p>Willingness to work in a matrix environment and to value the importance of teamwork.</p></li><li><p>Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.</p></li><li><p>Strong interpersonal, verbal, and written communication skills.</p></li><li><p>Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.</p></li><li><p>Effective time management in order to meet study needs, team objectives, and department goals.</p></li><li><p>Developing ability to work across cultures.</p></li><li><p>Shows commitment to and performs consistently high-quality work.</p></li><li><p>Ability to successfully work in a (‘virtual’) team environment.</p></li><li><p>Consulting Skills</p></li><li><p>Great attention to detail.</p></li><li><p>Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.</p></li><li><p>Holds a driver’s license where required.</p></li></ul><p></p><p><u><b>Knowledge and Experience:</b></u></p><ul><li><p>Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology</p></li></ul><p><br /><u><b>Education:</b></u></p><ul><li><p>Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience</p></li></ul>",
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