Job Description

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

What You’ll Do

• 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 Standard Operating Procedures (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 Standard Operating Procedure (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 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.
• 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

Regionally-Specific Essential Functions:

• APAC
  • 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
• LATAM
  • 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
• 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)
• North America:

• 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

What You Bring

• 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
• 1-2 years of experience in clinical research related field; candidates with fewer years of experience may be considered based on professional experience and/or education
• General knowledge of medical and pharmaceutical terminology
• General knowledge of the drug development and clinical trial process
• General knowledge of ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirements
• Strong verbal and written communication skills, organizational and record retention skills, customer service and interpersonal skills
• Ability to successfully work within a team-based environment, independently with minimal oversight
• Proven ability to handle multiple tasks and manage time efficiently
• Strong computer literacy and proficient with Microsoft Office Suite
• Ability to quickly learn and adapt to new systems and technologies

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

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