Clinical Project Assistant

**Clinical Project Assistant**
**Job Purpose/Summary**
Responsible for supporting management efforts of Clinical Project Managers and Directors, ensuring timelines, 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 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
- 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 mínimal 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 - Click here to learn more about "The CTI Way"
- We think globally and act locally - We have a global philanthropic program supporting our team's efforts to improve their local communities (Click here to learn more about our "CTI Cares" program)
- We are looking toward the future - We have had a consistent 15% growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate
- 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
**This position is office based and we look to fill at either our Sao Paulo office location.**
**CTI Clinical Trial and Consulting Services

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