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Site Readiness Specialist
vor 5 Monaten
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
We are strengthening our Start-Up Operations Department in Germany and are looking for a Site Readiness Specialist, serving as local expert in project start-up activities.
**Responsibilities**:
- Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements.
- Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable
- Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g. INDs/CTAs) and liaise with them as applicable regarding submission/approval
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable)
- Perform a review of final submission documents as applicable
- Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards
- Prevent and escalate study issues appropriately and in a timely fashion
- Assist in the upload of submission documentation to, interacting with and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within
the timelines mandated.
Required experience and qualifications:
- Minimum of 2 years of experience in clinical development or start up/ regulatory process.
- Working knowledge of ICH, RA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites
- Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
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