Project Coordinator I

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

📋 Description

• Provide administrative and coordination support for site activation activities and site-specific deliverables throughout the clinical trial lifecycle.

• Prepare investigator sites for clinical trials by reviewing and approving essential clinical trial and regulatory documentation.

• Establish site activation timelines and coordinate activities to achieve planned objectives.

• Communicate effectively with clinical sites, study teams, and external site personnel.

• Collaborate with various functional departments to align activities with site activation goals.

• Escalate risks related to the site activation schedule to the Project Manager.

• Collect, review, file, and distribute essential site documents.

• Ensure the quality and completeness of documentation for the initial site activation review.

• Maintain the electronic Trial Master File and study documentation.

• Produce meeting minutes and keep the ADI log updated.

• Coordinate training assignments, reconciliation, and documentation specific to projects.

• Assist with study documents, study plans, local ethics submissions, system access, Investigator’s Study Files, and Investigators’ Meetings.

• Maintain project timelines, enrollment tracking tools, and inventory of study materials.

• Prepare shipments of study supplies to clinical sites when necessary.

• Support CRAs with payment reconciliation, project tracking, status reporting, inspections, audits, and the preparation of corrective/preventive actions.

• May undertake project management responsibilities for designated trials.

• Engage in administrative tasks required to achieve project and team objectives.

⛳️ Requirements

• Bachelor’s degree in a relevant field related to clinical research or equivalent experience.

• Experience in clinical research within the biotechnology, pharmaceutical, and/or CRO industry is an advantage.

• Excellent oral and written communication skills in English; proficiency in French is a plus.

• Strong knowledge and proficiency in Word, Excel, and PowerPoint.

• Ability to prioritize multiple assignments and work effectively under pressure.

• Attention to detail and capability to meet deadlines.

• Quick learner with good adaptability and versatility.

• Strong organizational, communication, problem-solving, and multitasking abilities.

• Must possess legal authorization to work in Romania.

🏝️ Benefits

• Permanent full-time position.

• Flexible work schedule.

• Vacation time.

• Remote work opportunity.

• Continuous learning and development.

• Attractive opportunities for career advancement.

• Recruitment and selection accommodations available for applicants with disabilities, upon request.