Freelance Regional Clinical Trial Coordinator

This is a fully remote position, open to applicants in Poland.

📋 Description

• Assists in the preparation of Investigator Site Files (ISFs).

• Acts as the point of contact, providing communication and guidance to the Clinical Research Associate (CRA) and sites as directed by the Trial Manager.

• Responsible for the upkeep of the Trial Master File (TMF) or the CRO Project File, ensuring periodic reviews for accuracy and completeness.

• Timely uploads of Country and Site level documents into Veeva Vault.

• Ensures the prompt transfer of Study documents (scanned copies) to the Sponsor, as per agreement, on an ongoing basis.

• Aids in the preparation of document packages for submission to Competent Authorities (CA) and Ethics Committees (EC), along with support for EU Clinical Trial Regulation submissions.

• Facilitates communication among stakeholders regarding documentation management.

• Provides assistance to stakeholders in planning, collecting, filing, confirming, and archiving trial records as required.

• Supports stakeholders in verifying record availability at specific timepoints, in accordance with Sponsor procedures.

• Prepares for Sponsor/Rho team meetings and drafts meeting minutes.

• Maintains tracking information for Study activities.

• Assists the Trial Manager with data entry and system maintenance (including the correction of erroneous data entries).

• Supports the CRA in maintaining the ISF at the site.

• Aids sites in gaining access to systems as necessary.

• Assists the Trial Manager in sharing updates with sites.

• Provides support during audits and/or inspections.

⛳️ Requirements

• Experience in clinical trial coordination or similar administrative roles.

• Proficiency in the English language.

• Strong computer literacy.

• A university degree in a field relevant to the position is preferred.

• Advanced understanding of ICH-GCP guidelines.

• Exceptional communication skills (including reading, verbal, and written in both the local language and English) along with excellent organizational abilities.

• Proficient in managing multiple assignments and working independently.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Collaborative and supportive work environment.