Clinical Trial Project Coordinator: Start-Up & PM Support

CTI; Raleigh, Covington (NC, KY); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid work opportunities

Tuition reimbursement

Health benefits

Job summary

CTI Clinical Trial and Consulting Services is seeking a Clinical Project Coordinator to support management efforts of Clinical Project Managers and Directors across all phases of trials. The role is office-based in Covington, KY or Raleigh, NC.

You will help prepare plans, reports, site communications and TMF maintenance, while tracking scope, timelines and budgets. A bachelor’s in allied health and 1+ year of clinical research experience are required.

Qualifications

• 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

Responsibilities

• Support Clinical Project Manager / Director in completing clinical project management activities; support activities throughout all phases of a clinical project, including any SOP-required deliverable as appropriate
• Update Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support Clinical Project Manager / Director with issue resolution
• Assist Clinical Project Manager / Director or Clinical Research Manager / Clinical Operations Director with preparing data reports for site and Clinical Research Associate (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 presentations and documents as required per CTI SOPs
• Prepare 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
• Assist with tracking 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
• Manage and maintain CTI clinical system user account requests
• 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
• Support and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activities
• Assist the clinical project team and/or the Feasibility Department with developing feasibility surveys and survey content; participate in feasibility calls; assist with any site follow-up needed throughout start-up
• Assist clinical project team with tracking and filing of clinical project plan and/or SOP-related deviations
• Support and maintain 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
• 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
• Assist with the management of 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.)
• Provide support in developing new Clinical Project Coordinators, Clinical Project Assistants, and Research Associates (RAs) in clinical projects
• Assist with orientating new Clinical staff
• Provide third party vendor support
• Represent CTI in professional manner and foster collaboration with all clinical project teams / functional departments; assist in promoting interdepartmental cohesiveness

Education

Bachelor’s degree in allied health fields

Job description

CTI Clinical Trial and Consulting Services is seeking a Clinical Project Coordinator to support management efforts of Clinical Project Managers and Directors across all phases of trials. The role is office-based in Covington, KY or Raleigh, NC.

You will help prepare plans, reports, site communications and TMF maintenance, while tracking scope, timelines and budgets. A bachelor’s in allied health and 1+ year of clinical research experience are required.