Project Coordinator

About The Role

About The Role The Project Coordinator supports the end-to-end execution of clinical trials by coordinating study activities, evaluating study information, tracking risks, maintaining inspection-ready documentation, and exercising judgment to prioritize actions, identify issues requiring escalation, and support timely decision-making in collaboration with the Project Manager (PM), study team, sponsors, vendors, and internal stakeholders.

Develop, maintain, and evaluate project-specific timelines in collaboration with the PM to support on-time execution and delivery from project award through archival. Coordinate study-related issues in partnership with the PM, assess urgency and potential impact, and elevate matters appropriately. Maintain effective and timely communication with internal and external stakeholders, including sponsors, clinical sites, vendors, and cross-functional study team members, to support alignment and resolution of outstanding items.

Prepare, support, and document internal and external project team meetings, including tracking decisions, action items, follow-ups, and items requiring PM or leadership input. Support the development, review, and maintenance of project-specific documents and plans. Create, maintain, and/or coordinate Trial Master File documentation and related study records to support inspection readiness, including identifying documentation gaps and driving follow-up to resolution. Coordinate with Quality Assurance and project team members to support GxP and regulatory compliance.

Coordinate start-up activities with vendors and external sites. Support submissions to institutional review boards and regulatory agencies. Participate in Lessons Learned meetings and contribute observations, process gaps, and improvement recommendations to support department and corporate initiatives. Maintain risk-related trackers or risk register items. Coordinate project-specific training documentation by tracking finalized documents, confirming required training audiences, and escalating missing or delayed training inputs when needed.

• High School Education or higher MS Word, Excel, One Drive, One Note, Outlook and Power Point Ability to read and interpret technical documents and industry specific manuals.
• Ability to write advanced reports and correspondence.
• Ability to speak effectively before groups of customers or employees of the organization.
• Excellent verbal and written communication skills.
• Well developed interpersonal skills are required.
• Personal/professional integrity and proven discretion in handling confidential information.
• Continuously enhances processes by identifying inefficiencies and ensuring high-quality, efficient work while supporting and sustaining change initiatives.
• Uses resources responsibly and efficiently, safeguards assets (physical and intellectual), and aligns actions with company policies.
• Takes ownership of responsibilities, proactively solves problems, and contributes to organizational success and employee satisfaction.
• Communicates clearly and respectfully in both written and verbal forms, listens effectively, and conveys information accurately.
• Delivers responsive, courteous, and knowledgeable support while addressing stakeholder needs with flexibility and professionalism.
• Prioritizes effectively, works independently, and regularly evaluates decisions to focus on high-impact activities.
• Demonstrates flexibility, embraces change, and proactively identifies opportunities for improvement and innovation.
• Ability to develop strong trusting relationships in order to gain support and achieve results.
• Capable of managing multiple conflicting priorities.
• Must be self-directed, motivated, and have…