Clinical Trial Associate (LATAM)

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Requirements:

• High School Diploma/Certificate or equivalent combination of education, training, and experience; preferred Bachelor's degree.
• Knowledge of Good Documentation Practices.
• Knowledge of Good Clinical Practices.
• Strong command of English language, both written and verbal.
• At least 1 year of experience in clinical research on CRO side preferred.
• Experience using eTMF, ISF/ISP preferred.
• Excellent communication, organizational, and listening skills.
• Ability to confront constructively and foster learning.
• Representative, outgoing, and client-focused.
• Effective organizational, managerial, and time management skills.
• Strong analytical and problem resolution skills.
• Demonstrated ability to lead by example and maintain integrity.
• Ability to establish effective working relationships.
• Ability to work in a fast-paced environment.
• Proficiency with computer applications like Word, Excel, and PowerPoint.

Responsibilities:

• Perform quality check of documents prior to eTMF submission to ensure completeness and accuracy.
• Act as Document Submitter for country and site level documents in eTMF and resolve rejections.
• Assist with resolution of periodic QC findings for country and site eTMF.
• Maintain study wet-ink documents temporarily and prepare shipment to clients at study end.
• Communicate with the TMF Lead/Project Specialist on eTMF status.
• Update Expected Documents List in eTMF.
• Maintain Public Folders according to Study Correspondence Management Plan.
• Prepare and distribute Investigator and Pharmacy Site Files for Site Initiation Visits.
• Maintain QC/Inventory Checklists to support CRA during site visits.
• Assist CRA with reconciliation of ISF/PSF vs. TMF for inspection readiness.
• Assist CRAs/CTLs with query resolution and action item metrics follow up.
• Perform translations or verification of study documentation as needed.
• Update and maintain site level CTMS.