Rho, an award-winning, stable, full-service CRO known for its collaborative, dynamic culture based in the US, is quickly expanding their presence in Europe. We are a thriving company, and we will deliver global full-service clinical development services and unmatched customer support – worldwide. Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges. At Rho, we believe in the power of passionate individuals working together to make a difference in clinical research. We are seeking a Freelance Regional Clinical Trial Coordinator to join us - this will be a full time (150 hours per month) freelance role. This is a home based position. 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
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