Site Readiness Specialist - Germany

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:

• Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team
• 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)

Did you know?

Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com .

We look forward to your application!

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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About the company

Laboratory Corporation of America Holdings, more commonly known as Labcorp, is an American S&P 500 company headquartered in Burlington, North Carolina.

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