Document Review Specialist

<h2>Job Overview:</h2><p style="margin: 0px;">Are you ready to discover your career at <strong>Labcorp Drug Development</strong>?</p><p aria-hidden="true" style="margin: 0px;"> </p><p aria-hidden="true" style="margin: 0px;">We are a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.</p><p style="margin: 0px;">A career at Labcorp Drug Development provides our employees the unique chance to create an immediate impact and difference in patient’s lives.</p><p aria-hidden="true" style="margin: 0px;">                                       </p><p style="margin: 0px;">We are recruiting for our regional team in EMEA and are currently seeking to hire a <strong>Document Review Specialist</strong>. This position can be office-based or home-based in <strong>Turkey</strong>.</p><p aria-hidden="true" style="margin: 0px;"> </p><p style="margin: 0px;"><span>A Document Review Specialist reviews Investigator Packages, Informed Consent Forms and Advertisements following project & country specific regulations as well as ICH-GCP, FDA and other regional guidance.</span></p><p aria-hidden="true" style="margin: 0px;"> </p><p style="margin: 0px;"><strong>Essential Job Duties:</strong></p><p style="margin: 0px;"> </p><ul><li><span style="font-size: 11.0pt;">Review Initial Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial </span></li><li><span style="font-size: 11.0pt;">Review Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines </span></li><li><span style="font-size: 11.0pt;">Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines </span></li><li><span style="font-size: 11.0pt;">File Informed Consent Form , Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF </span></li><li><span style="font-size: 11.0pt;">Review & Develop Study Plans that document the required quality of documents included in Green Light Packages following the available SOP with manager oversight </span></li><li><span style="font-size: 11.0pt;">Review revised Core Informed Consent Forms to reconfirm compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines </span></li><li><span style="font-size: 11.0pt;">Provide input for Corrective and Preventative Actions (CAPAs) related to Document Review activities including Informed Consent Form Review, Patient Recruiting material Review and Investigator Package Review</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;">University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)</p><h2>Experience:</h2><ul><li><span style="font-family: 'Times New Roman',serif; color: black;">Working knowledge of  ICH, FDA, IRB/IEC and other applicable regulations/guidelines; </span></li><li><span style="font-family: 'Times New Roman',serif; color: black;">Working experience in Green light document reviews/ Investigator package documents/Essential document review</span></li><li><span style="font-family: 'Times New Roman',serif; color: black;">Fluency in English </span></li></ul>