Document Review Specialist I is responsible for reviewing Informed Consent Forms and Advertisements following project and country specific regulations as well as ICH-GCP, FDA and other regional guidance. Document Review Specialist I may responsible for reviewing revised protocols and core ICF’s.
Summary of Responsibilities:
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Review Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
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Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
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File Informed Consent Form, Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF.
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Review protocol amendment to reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines.
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Review revised Core Informed Consent Forms to reconfirm compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
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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.
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And all other duties as needed or assigned.
Qualifications (Minimum Required):
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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)
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Fortrea may consider relevant and equivalent experience in lieu of educational requirements
Experience (Minimum Required):
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Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
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2 years’ work experience in clinical research
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Previous interaction with operational project teams preferred.
Preferred Qualifications Include:
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Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services)
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Good written and oral communication skills
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Well-developed organizational skills
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Excellent proof-reading skills
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Good time management skills with ability to consistently prioritize workload to accommodate multiple tasks and projects
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Ability to work independently within a flexible team environment
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Accuracy and Attention to detail
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Analytical and problem-solving skills
Physical Demands/Work Environment:
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Standard office environment.
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