Clinical Project Coordinator

What You'll Do

As a Clinical Project Coordinator, you will play a crucial role in supporting Clinical Project Managers and Directors throughout all phases of clinical projects. Your responsibilities will span from initial setup to ongoing management and documentation, ensuring smooth and efficient trial operations.

• Support Clinical Project Manager / Director in completing management activities across all phases of a clinical project, providing back-up as needed.
• Update Clinical Project Manager / Director on progress, outstanding items, and issues, assisting with issue resolution.
• Assist Clinical Project Manager / Director with preparing data reports for site and Clinical Research Associate (CRA) management and provide support for site management activities.
• Develop initial drafts of clinical project plans, manuals, presentations, and other clinical project documents, ensuring they align with CTI Standard Operating Procedures (SOPs).
• Prepare initial drafts of internal and external reports, newsletters, and other clinical project communications, distributing them to relevant stakeholders.
• Assist with tracking project scope and internal financial reporting.
• Prepare initial drafts of detailed meeting agendas and minutes, and attend routine internal and external team meetings.
• Monitor and maintain tracking tools, clinical systems, and shared document repositories for clinical project management.
• Support the review and tracking of site pre-screening, screening, and enrollment activities, as well as subject status information, following up on identified issues.
• Support tracking of action items and internal team follow-up.
• Support and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up.
• Assist the clinical project team with developing feasibility surveys and content, participating in calls, and assisting with site follow-up.
• Assist Clinical Project Manager / Director with documenting clinical project and SOP-related deviations.
• Support and maintain clinical project documents in paper and/or electronic Trial Master Files (TMFs), and assist with TMF reconciliation and review follow-up.
• Participate in preparing for and following-up from internal and external audits, including direct participation as needed.
• Assist with the management of all clinical project-related supplies and drug management.
• Assist other departments (e.g., Regulatory Affairs Study Start-up, Data Management, Safety) throughout all phases of clinical projects.
• Provide support in developing new Clinical Project Coordinators, Clinical Project Assistants, and Research Associates (RAs).
• Assist with orientating new Clinical staff.
• Provide third party vendor support.
• Represent CTI in a professional manner, fostering collaboration across all clinical project teams and functional departments, and promoting interdepartmental cohesiveness.

What You'll Bring

We are seeking a dedicated professional with a solid foundation in clinical research and a commitment to advancing patient therapies.

• Bachelor’s degree in allied health fields such as nursing, pharmacy, or health / natural science, or an equivalent combination of education and relevant work experience.
• Minimum of 1 to 3 years of experience in a clinical research-related field.

Why CTI?

CTI Clinical Trial and Consulting Services offers a dynamic and supportive environment where your work directly impacts critically-ill patients globally. We are committed to employee growth, education, and fostering a collaborative culture.

• Career Progression: We support internal promotions, offering a structured mentoring program and dedicated programs for recent graduates.
• Education & Training: Benefit from tuition assistance, university partnerships, and a dedicated training department.
• Valued People: Enjoy generous vacation time, a hybrid work-from-home schedule, and a company culture that prioritizes work-life balance.
• Unparalleled Culture: Join a team consistently recognized as a top place to work and a leading CRO in the industry.
• Global Reach, Local Impact: Work with colleagues in 60 countries while maintaining strong connections to local communities through CTI Cares Committees.
• Future-Focused Growth: Be part of a company with consistent double-digit growth, investment in cutting-edge technology, and a high annual retention rate of 95%.
• Meaningful Work: Directly contribute to bringing life-changing therapies to market for chronically and critically-ill patients.

Key skills/competency

• Clinical Project Management
• Clinical Trials Operations
• SOP Adherence
• Documentation Management
• Data Reporting
• Site Management
• Vendor Oversight
• Trial Master File (TMF)
• Audit Preparation
• Cross-functional Collaboration