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Clinical Start up Specialist

Laboratory Corporation of America Holdings (Covance)

WARSAWA, Poland

<p><b>WHO ARE WE?</b><span><span> </span></span></p><p><span>As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.</span><br /><br /><span>Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.</span></p><p></p><p><b>THE JOB RESPONSIBILITIES:</b></p><ul><li>Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance</li><li>Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines</li><li>Prepare submissions to the IEC, and regulatory authorities if Global Regulatory Services (GRS) requires input. Liaise with the applicable IEC and/or regulatory authorities (if applicable) regarding submission/ approval issues.</li><li>Liaise with the Regulatory department regarding document submission requirements, if applicable</li><li>Customize country and site specific patient informed consent forms for compliance with local requirements and protocol</li><li>Proactively resolve informed consent issues and other potential difficulties with study sites</li><li>Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner</li><li>Proactively manage sites to ensure timely site activation and escalate study issues appropriately and in a timely fashion</li><li>Participate in team meetings to progress trials and identify site issues that might impact the timelines</li><li>Provide accurate projections and timelines to study teams</li><li>Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making the company ready for an audit at any time</li></ul><p></p><ul><li><b>Education/Qualifications:</b><span> </span><ul><li>University degree (life sciences preferred)</li></ul></li><li><b>Experience:</b><span> </span><ul><li>Minimum of 1- 2 years of experience in start-up/ regulatory process</li><li>Working knowledge of ICH, IEC and other applicable regulations/guidelines</li><li><b>Previous experience in performing submissions independently</b></li><li>Familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites</li><li>Good organizational and time management skills</li><li>Excellent communication skills</li><li>Detail and process oriented</li><li>Positive attitude and approach</li></ul></li></ul><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>

Job posted: 2022-05-26

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