CTI Clinical Trial Services

About CTI Clinical Trial Services

CLINICAL PROJECT ASSISTANT Job Purpose/Summary Responsible for supporting management efforts of Clinical Project Managers and Directors, ensuring timelines, budgets and quality standards are being achieved. What You’ll Do 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 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 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 Regionally-Specific Essential Functions Europe: Conduct unblinded pharmacy visits according to (unblinded) Monitoring Plan Assist with the submission and tracking of safety and regulatory reporting (e.g., SUSAR, DSUR) to central ethics committees and competent authorities in applicable countries Prepare and compile binders for ethics and competent authority submissions Prepare the notifications to local authorities in relevant countries as per local clinical studies law What You Bring 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 Strong organizational and record retention skills Strong customer service and interpersonal skills Ability to successfully work within a team-based environment Ability to work 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? We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade Our culture is unparalleled – Are you interested? Then we look forward to your electronic application, with a tabular CV in English, as well as information about your earliest possible starting date and your salary expectation! CTI Clinical Trial and Consulting Services Europe GmbH Frau Samy Weise Schillerstrasse 1/15 | 89077 Ulm, Germany For your application, please use the following link: https://jobapply.page.link/GUvS www.ctifacts.com

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