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Título: Document Review Specialist (based in Latin America)
Cidade/Estado: null / null
Job Overview:Are you ready to discover you next career at Labcorp Drug Development?A career Labcorp provides our employees the unique chance to create an immediate impact and difference in our patient’s lives.will offer a rewarding career, a chance to work in an energetic & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. Covance by Labcorp is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.We are recruiting for our Team in Latin America are currently seeking to hire a Document Review Specialist. This position could be based in Argentina, Brazil or Mexico.A Document review Specialist I is reviewing Investigator Packages, Informed Consent Forms and Advertisements following project & country specific regulations as well as ICH-GCP, FDA and other regional guidance.All essential job duties:Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trialReview Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelinesReview Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelinesFile Informed Consent Form , Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMFReview Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversightReview protocol amendment to reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines Review revised Core Informed Consent Forms to reconfirm compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines 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 ReviewEducation/Qualifications:Recommended: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)Experience:Minimum Required:Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; .2 years work experience in clinical researchPrevious interaction with operational project teams preferred
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