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.
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 are now looking for Start-up Specialist for our team in Hungary, Budapest. This is a fully home based position.
Job Summary:
Primary contact with assigned investigative site(s) during site start-up activities and maintenance with the responsibility for:
- collection of the required investigator and essential documents for a study
- submissions to the EC/RA and performing any other local applications (as required) within the timelines agreed with project management
- ensuring that the documentation meets the specifications required by applicable regulations and sponsor.
Serves as local expert in project start-up activities for a particular country or region.
Essential Job Duties:
- prepare submissions to the Ethics Committees and Regulatory Authorities; liaise with the applicable EC/RA regarding submission/ approval issues
- ensure high quality documents are filed and systems are updated on an ongoing and timely basis making the company ready for an audit at any time
- collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance
- ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
- serve as primary contact for investigative sites and ensure documents required are collected in a timely manner. Proactively manage sites to ensure timely site activation and escalate study issues appropriately and in a timely fashion.
Experience:
- Experience in clinical trials within a CRO or a pharmaceutical company with a specialization in clinical study start up / regulatory processes
- Good understanding of research protocol requirements as well as the ability to communicate them / educate others about them
- Ability to collaborate successfully with operational project teams as well as external investigative sites and local regulatory authorities (including IRBs and IECs)
- Experience with submissions to the Hungarian regulatory authorities - observing all local regulations and guidelines as well as international standards such as ICH and GCP
- Familiarity with investigator start-up documents
- Hungarian & English – both spoken and written – is a must
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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