About this role
Summary of Responsibilities:
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Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks
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Support system compliance and system data entry, as applicable
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File required task-related documentation in the Electronic Trial Master File (eTMF)
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Review initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines.
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Liaising and follow-up with local teams, Start-up Project Managers, and Sponsors to assure timely approval of Informed Consent Forms in order to meet submission deadlines.
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
Learn more about our EEO & Accommodations request here.