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

o 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

o Support RWE activities as needed in the region

o 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

email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ) 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.