Freelance Regional Clinical Trial Coordinator
Posted 1hrs ago
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Job Description
Freelance Regional Clinical Trial Coordinator at Rho, a global CRO, handling clinical trial documentation and stakeholder communication across Europe.
Responsibilities:
- 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












