Freelance Regional Clinical Trial Coordinator

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

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