Start-up Specialist, Phase I

Responsibilities

• Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries
• Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable
• 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
• Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable]
• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
• Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision
• 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
• Participate in team and project meetings as applicable
• When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams
• 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
• 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
• Proactively identifying and escalating to Submission Leads any risk to meeting deliverables
• Notify the Submissions Lead of hours identified as Out-of-Scope or overburn
• Performs all other duties as needed or assigned

Preferred

• life science

Benefits

• Remote work arrangement
• Global clinical research organization providing clinical development solutions.
• Durham, North Carolina, USA
• https://www.fortrea.com
• Distribution of Different Job Fields Receiving Sponsorship
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• 2026-09-12

Qualifications

• 2+ years of start-up experience
• residing with the U.S
• 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)
• 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements
• In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered
• 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
• Residing with the U.S
• Life science
• 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
• In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered.
• Minimum of 2 years of experience in clinical development or start-up/ regulatory process.

Required skills

• Clinical Research, Study Start-Up, ICH Guidelines, Regulatory Authority Submissions, IRB/IEC Regulations, Investigator Start-Up Documentation, Research Protocol Requirements, Site Contract and Budget Negotiation

Preferred skills

• life science

Experience

• 2+ years