Clinical Project Coordinator/Clinical Trial Assistant

About the Opportunity

Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project; provide back-up management as needed

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 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

Support the review and tracking of site pre-screening, 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 with developing feasibility surveys and survey content; participate in feasibility calls; assist with any site follow-up needed throughout start-up

Assist Clinical Project Manager / Director with documenting clinical project and 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

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

About You

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

Minimum of 1 to 3 years of experience in clinical research related field

Benefits

• We support career progression
• We value education and training
• We value our people
• Our culture is unparalleled
• We think globally and act locally
• We are looking toward the future
• Our work makes a difference

About Company

We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market