Clinical Project Assistant

Clinical Project Assistant / Coordinator (Level Dependent Upon Experience) Job Category : Clinical Project Mgmt Requisition Number : CLINI Posted : November 11, Full-Time On-site Locations Showing 1 location Description About CTI 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 What You'll Do Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project; Provide support for site management activities to Clinical Project Manager / Director and CRA; Maintain clinical project documents in paper and / or electronic Trial Master Files and perform TMF reconciliation and period review follow-up; Prepare Investigator Site Files; Prepare initial drafts, including templates and content, of internal reports, external reports, newsletters, and other clinical project communications and plans; distribute reports and communications to sites, vendors, Sponsors, and internal team members; 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 and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activities. 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? We support career progression – 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, and have provided cash bonuses every year for the past decade. Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry. We think globally and act locally – We have a global philanthropic program supporting our team's efforts to improve their local communities. We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%). Our work makes a difference – 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. 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 () or from our verified LinkedIn page. 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. #J-18808-Ljbffr