Start up Associate

<p>Primary contact and liaison with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB submissions are made within the timelines agreed with project management and Start-up team.</p><p>- Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance - - 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</p><p>- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner. -</p><p>- With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements. - May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.</p><p>- Escalate study issues appropriately and in a timely fashion.</p><p>- Update study documents when there are changes in study personnel/study amendments.</p><p>- Contribute to the preparation of submissions to IRB/IEC with appropriate supervision.</p><p>- Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.</p><p>- Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision.</p><p>- Perform other duties as assigned by management.</p><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>