CPA

About The Job

Responsible for supporting management efforts of Clinical Project Managers and Directors, ensuring timelines, budgets and quality standards are being achieved.

What You'll Do

• 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 with assigned tasks/responsibilities as they arise
• 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
• Assist in development of initial drafts of clinical project plans, manuals, presentations, and other clinical project documents for review; update as requested by clinical project team
• Under the direction of the clinical project team, prepare initial drafts of internal reports, external reports, newsletters, and other clinical project communications; distribute reports and communications to sites, vendors, Sponsors, and internal team members
• Prepare initial drafts of meetings agendas and minutes in collaboration with Clinical Project Manager; attend routine internal and external team meetings
• 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
• Support tracking of action items
• 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; participate in feasibility calls; assist with site follow-up needed throughout start-up
• Assist clinical project team with tracking and filing of clinical project plan and/or Standard Operating Procedure (SOP)-related deviations
• Receive and submit/distribute clinical project-related documentation; set up and maintain paper and electronic Trial Master Files; and support TMF reconciliation and periodic review follow-up
• Create and compile the Investigator Site File and Pharmacy Binde or Study Manual in collaboration with CPM/RASSU/Clinical Monitoring. Organize shipments to CRA/Site. Includes set-up and maintenance of Index with Comments.
• Assist clinical project team with internal and external audit preparation and follow-up
• Assist with the provision of all clinical project-related supplies and drug management; compile and ship supplies to sites
• 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 Assistants and Research Associates (RAs) in clinical projects
• Assist with orientating new Clinical staff
• Provide third party vendor support
• Represent CTI in a professional manner and foster collaboration with all clinical project teams/ functional departments; assist in promoting interdepartmental cohesiveness Regionally-Specific Essential Functions:
  
  

 MEA

• Manage receipt and first review of site and vendor invoices, process subject milestones payments per scope, prepare payment requests for internal review / approval, assist in the preparation of payment projections, and maintain payment records; escalate any issues with invoices to Clinical Project Manager / Director
• Support RWE activities as needed in the region
• Report to Clinical Research Manager (CRM)
  
  

What You Bring

0-2 years of experience in clinical research related field; candidates with fewer years of experience may be considered based on professional experience and/or education

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message.
• We will never ask for your bank account information at any point during the recruitment process.