Job Description

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

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

Please submit your CV/resume in English.