Principal Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to project teams as a study lead and cross-functional liaison.

• Organize and facilitate project activities while managing administration for assigned projects.

• Serve as a buddy during onboarding and provide training for new staff members.

• Identify training needs and support both departmental and cross-functional process enhancement initiatives.

• Aid in the development of the critical path for site activation and act as an escalation point for the project team.

• Coordinate, supervise, and execute assigned trial activities in accordance with task matrices.

• Conduct reviews of department, internal, country, investigator files, and eTMF, documenting findings.

• Ensure that assigned tasks are completed punctually, within budget, and meet quality standards.

• Maintain study documentation, team lists, training trackers, system access, activity plans, and vendor trackers.

• Assist with risk-based monitoring activities and administrative trial tasks.

• Schedule client and internal meetings and prepare meeting minutes.

• Review and monitor local regulatory documents and support audit readiness and responses.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Coordinate Investigator Site File and Pharmacy binder materials along with study supplies.

• Support translation materials and ensure translation quality control.

• Provide system support for Activate and eTMF, ensuring databases are up to date.

• Collaborate locally to plan and execute submissions in alignment with global strategies.

• Train personnel, functional team members, investigators, and clients as required.

• Act as an alliance-level lead for client integration and eTMF activities.

• Facilitate site activation through site agreements, budgets, essential documents, regulatory packages, site lists, site interest plans, surveys, and site communications.

• Conduct site feasibility interviews and offer local insights on site capacity and investigator experience.

• Address investigator inquiries and maintain account and contact information.

• Contribute to global feasibility processes, best practices, and the identification of new sites.

• Serve as a subject matter expert on feasibility survey tools.

⛳️ Requirements

• High/Secondary school diploma or equivalent along with relevant formal academic/vocational qualifications.

• Prior experience that provides the knowledge, skills, and abilities necessary for the role, equivalent to at least 6 years.

• Bachelor's degree is preferred.

• Capability to work collaboratively in a team or independently.

• Exceptional organizational skills with a keen attention to detail.

• Ability to analyze project-specific data and systems effectively.

• Flexibility and adaptability to changing project timelines.

• Familiarity with applicable country regulations, ICH Good Clinical Practices, organizational/client SOPs, and WPDs.

• Excellent command of the English language and grammar, along with proficient local language skills as necessary.

• Strong presentation skills.

• Proficient in MS Office (Word, Excel, PowerPoint).

• Ability to learn and master clinical trial database systems.

• Capacity to successfully complete the organization's clinical training program.

• Strong interpersonal, oral, and written communication abilities.

• Problem-solving skills.

• Good negotiation capabilities.

• Basic knowledge of medical/therapeutic areas and medical terminology.

• Basic understanding of local health systems.

• Ability to work effectively in a matrix environment.

• Skills in risk management and escalation.

• Occasional driving to site locations and potential for occasional travel.

🏝️ Benefits

• Full-time employment.

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Potential for occasional travel as needed.