Freelance Regional Clinical Trial Coordinator

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Rho

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1984

💳 Fintech

🤝 B2B

🏦 Banking

Fintech • B2B • Banking

Rho is a financial technology company that provides integrated banking solutions for businesses, combining modern banking with cash management and expense tracking. Their platform focuses on streamlining financial operations and offering a user-friendly interface for better control of company finances.

📋 Description

• Supports in preparation of ISFs (Investigator Site Files). • Contact, communication and guidance to CRA and sites as instructed by Trial manager • Maintenance of TMF (Trial Master File) or the CRO Project File and periodically review the TMF and/or CPF to ensure accuracy, completeness. • Upload Country and Site level documents in Veeva Vault in a timely manner. • Timely transfer of Study documents (scanned copies) to Sponsor, as agreed, on an ongoing basis. • Supports in preparation of documents package for submission to CA (Competent Authorities) and EC (Ethics Committee), and support for EU CTR submissions • Facilitate the communication between stakeholders in regards to documentation management • Provide support to stakeholders on the planning, collecting, filing, confirming, archiving of trial records, as needed • Support the stakeholders to confirm records availability at specific timepoints, as required by Sponsor procedures • Sponsor/ Rho team meetings preparation, drafting meeting minutes. • Maintains tracking information for Study activities. • Support Trial Manager on data entry and maintenance to systems (includes correction of wrong data entry) • Supports CRA (Clinical Research Associate) in maintaining ISF at Site. • Support sites getting access to systems, as needed • Support Trial Manager sharing updates with sites • Support on audits and/or inspections

🎯 Requirements

• Experience in clinical trial coordination or related administrative roles. • English language • Computer literacy • Preferably university degree in position related field • Advanced knowledge of ICH-GCP guidelines • Excellent communication (including reading, verbal, and written in both local language and English) and organizational skills • Capabilities in managing multiple assignments and work independently