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.
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This is an exciting position as the Regulatory Clinical Trial Coordinator which will be dedicated to one sponsor.
What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.
Key responsibilities:
- 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.
- With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.
- May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.
- Escalate study issues appropriately and in a timely fashion.
- Update study documents when there are changes in study personnel/study amendments.
- Contribute to the preparation of submissions to IRB/IEC/RA with appropriate supervision. Support EU CTR submissions.
- Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Fortrea ready for an audit at any time.
- Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision. Perform country/site level feasibilities (Site ID)
- Perform other duties as assigned by management.
Education:
- Degree in a relevant field such as pharmacology, life sciences, clinical trial management, (veterinarian) medicine, health care (management), nursing, chemistry, biology
- In lieu of the above, an equivalent completed vocational education or equivalent professional experience
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 would be an asset
- Autonomous work style with excellent time and project management skills
- Business fluency in Greek & English – both spoken and written – is a must
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit
www.fortrea.com
.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea 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. For more information about how we collect and store your personal data, please see our Privacy Statement.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea 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.
For more information about how we collect and store your personal data, please see our
Privacy Statement
.
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