Hybrid Clinical Project Coordinator — Drive Trial Excellence

Socket.dev; Raleigh (NC); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health benefits

Hybrid work opportunities

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services is seeking a Clinical Project Coordinator to support management efforts of Clinical Project Managers and Directors, ensuring timelines, budgets, and quality standards are met. This office-based role will be filled at our Covington, KY or Raleigh, NC locations.

You will assist with project plans, reports, site management, TMF, audits, and coordination across departments to advance clinical trials for chronically and critically ill patient populations.

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 SOP-required deliverables.
• Update Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support issue resolution.
• Assist with 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 documents; assist in reviewing and maintaining these per SOPs.
• Prepare initial drafts of internal/external reports, newsletters, and other communications; distribute to sites, vendors, Sponsors, and internal teams.
• Assist with tracking project scope and internal financial reporting.
• Prepare drafts of meeting agendas and minutes; attend routine meetings.
• Monitor and maintain tracking tools, clinical systems and shared document repositories.
• Manage and maintain CTI clinical system user account requests.
• Support review/tracking of site prescreening, screening, enrollment and subject status; follow up on issues.
• Support tracking of action items and internal team follow-up.
• Support start-up activities and milestones, including site selection/start-up.
• Assist with feasibility surveys and calls; assist with site follow-up during start-up.
• Assist with tracking deviations for SOP-related activities.
• Support TMF reconciliation and period reviews.
• Create and compile Investigator Site File and Study Manual; organize shipments to CRA/Site; manage index with comments.
• Participate in audits and prepare follow-up from audits.
• Assist with management of clinical project-related supplies and drug management.
• Assist other departments during all phases of clinical projects.
• Support development of new Clinical Project Coordinators, Assistants, RAs.
• Assist with orientating new Clinical staff.
• Provide third party vendor support.
• Represent CTI professionally and foster cross-department collaboration.

Education

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

Job description

CTI Clinical Trial and Consulting Services is seeking a Clinical Project Coordinator to support management efforts of Clinical Project Managers and Directors, ensuring timelines, budgets, and quality standards are met. This office-based role will be filled at our Covington, KY or Raleigh, NC locations.

You will assist with project plans, reports, site management, TMF, audits, and coordination across departments to advance clinical trials for chronically and critically ill patient populations.