Start-up Associate
il y a 2 semaines
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 recruiting for our Site Readiness team in Belgium and are currently seeking to hire a Site Readiness & REG Specialist I with a full-time contract.
Responsibilities:
- Serve as local expert in project startup activities for a particular country or region.
- Act as a 'knowledge resource' to mentor and train new hires and lessexperienced department colleagues.
Essential Job Duties:
- 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.
- Participate in team meetings to progress trials and identify site issues that might impact the timelines.
- When needed, assist in preparation of Site Activation project specific plans and provide accurate projections and timelines to study teams agreed with the Sponsor Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.
- Liaise with Fortrea Regulatory department regarding document submission requirements, if applicable.
- Prepare submissions to IRB/IEC, and regulatory authorities if Global Regulatory Services (GRS) requires input. Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/ approval issues. 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.
- May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate.
- Undertake tasks delegated by senior team members, depending upon country and situational requirements.
- Perform other duties as assigned by management.
Experience:
- Minimum of 1 year of experience in clinical development or start up/ regulatory process.
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator startup 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
Education/Qualifications/Certifications and Licenses:
Level of education preferred (if required or experience level which may be substituted for level of education).
Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).
- 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) AND 1 year work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
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
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