Job Title: Clinical Trial Coordinator
Location: Flexible
Work Schedule: Other
Environmental Conditions: Office
Position Summary
The Clinical Trial Coordinator is responsible for supporting and managing trial activities within assigned clinical research projects. This includes coordinating administrative tasks, maintaining study documentation, and ensuring timely and quality execution of trial-related responsibilities. The role involves collaborating with internal and external stakeholders to achieve compliance with regulatory and organizational standards.
Key Responsibilities
Trial Activity Management
Coordinate and oversee trial activities detailed on the task matrix.
Conduct department, internal, country, and investigator file reviews, documenting findings and following up on resolutions.
Monitor allocated tasks to ensure they are completed on time, within budget, and to quality standards, and reassign tasks as needed for efficiency.
Study Documentation and System Support
Maintain study-specific documentation, including team lists, training records, system access, and activity plans.
Provide system support (e.g., CTMS, Oracle Activate, eTMF) by managing access requests, tracking documents, and ensuring audit readiness.
Identify and resolve compliance issues and suggest process improvements to study teams.
Administrative Support
Process and file essential documents in the organization’s or client’s eTMF system.
Conduct reviews of eTMF systems and coordinate issue resolution.
Organize and support meetings, including taking minutes and following up on action items.
Reporting and Metrics
Export and reconcile study metrics reports, analyze data, and identify issues if acting in a lead capacity.
Monitor and maintain vendor trackers to ensure accuracy and alignment with study requirements.
Study Setup and Coordination
Assist with compiling Investigator Site File (ISF) templates and pharmacy binders under the direction of the Clinical Team Manager.
Support initial study setup by attending project meetings, taking notes, and ensuring all initial documentation and processes are in place.
Qualifications
Education and Experience
High school diploma or equivalent, with relevant academic or vocational qualifications.
Previous relevant experience in clinical trial coordination or a related field, ranging from 0 to 4 years.
Skills and Competencies
Proficiency in using clinical trial management systems (CTMS), eTMF systems, and related tools.
Strong organizational and multitasking abilities with attention to detail.
Effective communication skills, both written and verbal.
Ability to work collaboratively with diverse teams and manage competing priorities.
Basic understanding of clinical research processes and regulatory requirements.
Why Join Us?
This role offers an excellent opportunity to contribute to impactful clinical research while developing your skills in trial coordination, compliance, and documentation. If you are detail-oriented, proactive, and eager to make a difference in healthcare innovation, we encourage you to apply.
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