Offer summary

Qualifications:

2-5 years clinical research experience in Germany, Life science background, fluency in German and English.

Key responsabilities:

Serve as main contact for study sites

Conduct site visits, oversee start-up activities

Collect regulatory documents, implement enrollment strategies

Manage Investigational Product and trial materials

Utilize systems to track subject status and related activities

Job 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 www.ctifacts.com

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

What You Bring

2-5 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 is a plus
Fluent (Level B2 to C1) in spoken and written language in German and in English
You need to be fully eligible to work in Germany. CTI does not offer any Sponsorship

Why CTI?

At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.

Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

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