Clinical Project Assistant / Coordinator For Our
Clinical Project Assistant / Coordinator for our Italian Team
**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
- 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 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?
At CTI, we recognize that our people are what make our company successful.
Our work moves medicine forward.
For that reason, we treat our team members with the respect they deserve, and our numbers show it:
- We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
- We value education and training - We provide tuition assistance, 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 three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked.
We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
- 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 - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work.
Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
- 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 annual retention rate of 95%, which is much higher than many other CROs
- 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
After an appropriate period of training, we offer you an unlimited, varied and attractive job in an international company.
CTI Clinical Trial and Consulting Services Europe GmbH
Frau Samy Weise
Schillerstrasse 1/15 | 89077 Ulm, Germany
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