Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.
As a Clinical Research Associate (level depends on experience) you will be responsible for the successful conduct of clinical trials and serve as main contact for the investigative site by representing CTI in a professional manner.
Tasks
What You’ll Do
- Serve as main CTI contact for assigned study sites
- Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
- Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection
- Collect, review and track essential/regulatory documents
- Participate in and complete all general and study specific training as required
- Participate in investigator, client and project team meetings; may include presentations
- Create and implement subject enrollment strategies for assigned study sites
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan
- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
- Assist with project-specific activities as member of Project Team
Requirements
What You Bring
- minimum 2-3 years clinical research experience as a CRA or related profession in Germany
- Life science background
- Excellent knowledge in ICH-GCP and regulatory requirement
- Experience in Transplant and AKI or oncology
- Fluent in spoken and written language in German and in English
Benefits
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 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 and a hybrid work from home schedule
- 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.
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 WeiseSchillerstrasse 1/15 | 89077 Ulm, Germany
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Zuletzt aktualisiert am 19.04.2024