Clinical Project Coordinator

Job Summary

The Clinical Project Coordinator position supports management efforts of Clinical Project Managers and Directors, ensuring timelines, budgets, and quality standards are met. This position is office-based and can be filled at our Covington, KY or Raleigh, NC office locations.

About the Role

Support Clinical Project Manager / Director in completing clinical project management activities; support activities throughout all phases of a clinical project, including any SOP-required deliverables as appropriate.

Responsibilities

• Update Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support Clinical Project Manager / Director with issue resolution
• Aid in preparing data reports for site and CRA management; provide support for site management activities
• Develop initial drafts of clinical project plans, manuals, presentations, and other clinical project documents; assist in reviewing and maintaining these documents as required per CTI Standard Operating Procedures (SOPs)
• Create initial drafts, including templates and content, of internal reports, external reports, newsletters, and other clinical project communications; distribute reports and communications to sites, vendors, Sponsors, and internal team members
• Track project scope and internal financial reporting; prepare initial drafts of detailed meeting agendas and minutes; assist in initial review of meeting documents prepared by others; attend routine internal and external team meetings
• Monitor and maintain tracking tools, clinical systems, and shared document repositories utilized for clinical project management
• Support the review and tracking of site prescreening, screening, and enrollment activities as well as subject status information; follow up with internal clinical project team and/or sites as necessary regarding any identified issues
• Support tracking of action items and internal team follow-up; assist with tracking of clinical project start-up activities and milestones, including site selection and site start-up activities
• Aid in developing feasibility surveys and survey content; participate in feasibility calls; assist with any site follow-up needed throughout start-up
• Aid in tracking and filing of clinical project plan and/or Standard Operating Procedure (SOP)-related deviations
• Create and compile the Investigator Site File and Pharmacy Binder or Study Manual in collaboration with CPM/RASSU/Clinical Monitoring. Organize shipments to CRA/Site. Includes set-up and maintenance of Index with Comments.
• Participate in preparing and following-up from internal and external audits; participate in audits as needed
• Aid in managing all clinical project-related supplies and drug management
• Assist other departments as needed throughout all phases of clinical projects (e.g., Regulatory Affairs Study Start-up, Data Management, Safety, etc.)
• Support and prepare / maintain tracking of clinical project documents in paper and/or electronic Trial Master Files and support Clinical Project Manager / Director with TMF reconciliation and period review follow-up
• Assist with the development of new Clinical Project Coordinators, Clinical Project Assistants, and Research Associates (RAs) in clinical projects
• Provide support in orientating new Clinical staff
• Represent CTI in a professional manner and foster collaboration with all clinical project teams / functional departments; assist in promoting interdepartmental cohesiveness

Requirements

• 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
• At least 1 year of experience in clinical research related field

Qualifications

• Strong organizational skills
• Excellent communication and interpersonal skills
• Proficiency in Microsoft Office Suite
• Ability to manage multiple tasks and priorities simultaneously
• Experience with clinical trial management software and systems

Skills

• Strong organizational skills
• Excellent communication and interpersonal skills
• Proficiency in Microsoft Office Suite
• Ability to manage multiple tasks and priorities simultaneously
• Experience with clinical trial management software and systems

Benefits

CTI offers a competitive compensation package, including a comprehensive benefits program that includes:

• Health insurance
• Dental insurance
• Vision insurance
• Paid time off
• Flexible work schedule
• Professional development opportunities
• Employee assistance programs

Pay

Compensation is commensurate with experience.

Schedule

This position is typically full-time, but may require some evening and weekend work depending on project needs.