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

📋 Description

• Conduct monitoring and site management activities to ensure that studies are performed and reported in accordance with the study protocol, relevant regulations and guidelines, as well as sponsor requirements.

• Carry out site selection, initiation, monitoring, and close-out visits.

• Ensure proper documentation is maintained.

• Assist in the creation of a subject recruitment strategy.

• Establish consistent communication channels with designated sites.

• Provide protocol and related study training to the assigned sites.

• Assess the quality and integrity of site practices and escalate any quality concerns as necessary.

• Monitor regulatory submissions, recruitment efforts, case report form (CRF) completion, and data query resolution to oversee study progress.

⛳️ Requirements

• A minimum of a Bachelor’s Degree in a scientific field or healthcare.

• At least 1 year of experience in on-site monitoring of clinical trials.

• Strong understanding of and experience with relevant clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Proficient in computer applications, including Microsoft Word, Excel, and PowerPoint.

• Capability to operate a laptop, iPhone, and iPad when necessary.

• Strong written and verbal communication skills.

• Proficiency in Polish and English.

• Ability to build and maintain effective working relationships with colleagues, management, and clients.