Document Reviewer I (TMF/ eTMF customization experience required)
Covance
BUENOS AIRES, AR
hace 6 días
source : DirectEmployers Association

Job Overview : + Review Country / Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines + Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines + File Informed Consent Form , Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF + 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 Review Education / Qualifications : + 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) + Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services) + Good written and oral communication skills + Well developed organizational skills + Excellent proof-reading skills + Good time management skills with ability to consistently prioritize workload to accommodate multiple tasks and projects + Ability to work independently within a flexible team environment + Accuracy and Attention to detail + Analytical and problem solving skills Experience : + Working knowledge of ICH, FDA, IRB / IEC and other applicable regulations / guidelines + 2 years work experience in clinical research + Previous interaction with operational project teams preferred Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority / Female / Individual with Disability / Veteran / Sexual Orientation / Gender Identity).

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