What You’ll Do

Si desea saber un poco más sobre esta posibilidad, o está considerando presentar su candidatura, por favor, lea la siguiente información del puesto.

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- 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. xqbhyrx 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

What You’ll Bring

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- 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

- Fluent in English

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📌 Clinical Project Assistant/ Coordinator (Madrid)
🏢 Cti Clinical Trial And Consulting Services
📍 Madrid