This is a fully remote position, open to applicants in Romania, +1 more country.

📋 Description

• Evaluate and implement study-specific plans that outline necessary expectations for assigned responsibilities.

• Assist in ensuring system compliance and manage system data entry as required.

• Organize and maintain task-related documentation in the Electronic Trial Master File (eTMF).

• Assess initial and modified Country/Site Informed Consent Forms (ICFs) to ensure adherence to Sponsor specifications, local regulatory standards, and Good Clinical Practice (GCP) guidelines.

• Collaborate and communicate with local teams, Start-up Project Managers, and Sponsors to ensure prompt approval of Informed Consent Forms and adherence to submission timelines.

⛳️ Requirements

• Bachelor's degree or equivalent from a university/college (preferably in life sciences) or certification in a relevant allied health field from a recognized institution (e.g., nursing certification, medical or laboratory technology).

• Fortrea may accept relevant equivalent experience as a substitute for formal educational qualifications.

• In-depth knowledge of ICH, FDA, IRB/IEC, and other pertinent regulations and guidelines.

• Minimum of 3 years of experience in clinical research.

• Proficiency in MS Office applications (Word, Excel, PowerPoint, Access, Outlook, and internet services).

• Exceptional written and verbal communication abilities.

• Strong organizational capabilities.

• Excellent proof-reading skills.

• Effective time management skills, with the ability to prioritize tasks and manage multiple projects efficiently.