Clinical Project Coordinator

Clinical Project Coordinator

CTI Clinical Trial and Consulting Services is seeking a motivated Clinical Project Coordinator to join our team.

What You'll Do

• Support Clinical Project Managers / Directors in completing management activities across all phases of a clinical project, providing back-up management as needed.
• Update Clinical Project Managers / Directors on progress, outstanding items, and issues, and assist with issue resolution.
• Assist with preparing data reports for site and Clinical Research Associate (CRA) management and support site management activities.
• Develop initial drafts of clinical project plans, manuals, presentations, and other project documents, and assist in their review and maintenance per CTI Standard Operating Procedures (SOPs).
• Prepare initial drafts of internal and external reports, newsletters, and other project communications, and distribute them to relevant parties.
• Assist with tracking project scope and internal financial reporting.
• Prepare initial drafts of detailed meeting agendas and minutes, assist in reviewing meeting documents, and attend routine internal and external team meetings.
• Monitor and maintain tracking tools, clinical systems, and shared document repositories used 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 any identified issues.
• Support tracking of action items and internal team follow-up.
• Prepare and maintain tracking of clinical project start-up activities and milestones, including site selection and start-up.
• Assist the clinical project team with developing feasibility surveys and content, participate in feasibility calls, and assist with site follow-up during start-up.
• Assist 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 period review follow-up.
• Participate in preparing for and following up from internal and external audits, and participate in audits as needed.
• Assist with the management of all clinical project-related supplies and drug management.
• Provide support to other departments as needed 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 professionally and foster collaboration with all clinical project teams and functional departments.

What You'll Bring

• Bachelor’s degree in allied health fields (nursing, pharmacy, 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?

• Career Progression: We promote from within, with a structured mentoring program and initiatives for recent graduates.
• Education & Training: We offer tuition assistance, university partnerships, and a dedicated training department.
• People Value: Guaranteed full pay during COVID-19 shutdowns, generous vacation time, and a hybrid work-from-home schedule support work-life balance.
• Unparalleled Culture: Recognized as a best place to work and a top CRO.
• Global Reach, Local Connection: Employees in 60 countries with strong local community ties via CTI Cares Committees.
• Future-Oriented: Consistent double-digit growth, investment in cutting-edge technology, and a 95% average annual retention rate.
• Meaningful Work: Focus on treatments for chronically and critically-ill patients, bringing life-changing therapies to market.

Key skills/competency

• Clinical Project Management
• Clinical Trial Operations
• Regulatory Affairs
• Data Management
• TMF Management
• Site Management
• Clinical Research Associate
• Project Planning
• Budget Tracking
• Vendor Management