Start Up Specialist

You are looking to contribute your talents to a team that values excellence and collaboration? Fortrea is here!

Job Overview

You will have full accountability in the delivery of site start-up activities of your assigned clinical studies.

Among your main responsibilities you will:

• Ensure timely collection of site/investigator and regulatory documents
• Provide accurate projections and timelines for site activation
• Prepare EU CTR Part II/Ethics Committee/Regulatory Authorities submission packages, in accordance with relevant regulations
• Customize Country and Site Documents especially Participant Information Sheet and Informed Consent Form
• Negotiate site contracts and budgets
• Ensure ongoing accuracy and quality of site/study documents, (e)TMF filing and that systems are updated on an ongoing basis
• Serve as local expert in project start-up activities for a particular country or region.
• Act as a 'knowledge resource' to mentor and train new hires and less-experienced department colleagues if suitable.

Qualifications (Minimum Required)

• Fluent in French and English
• University degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical, pharmacy or laboratory)
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements

Experience (Minimum Required)

• This role will make a difference in our team, improving our way of working and actively seeking local efficiencies within global processes. This is why we need you to bring a minimum of 3 years working experience in clinical development or clinical start-up/regulatory process.
• Working knowledge of ICH GCP, EU CTR and other applicable regulations/guidelines (MDR and IVDR are a plus); familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and sites.
• Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.

Physical Demands/Work Environment

• General Office Environment.

Learn more about our EEO & Accommodations request here .