Remote Site Start-Up Lead

Meeveem Limited; Maidenhead; On-site; GBP 42,000 - 62,000; Full time

Benefits offered by this job

Remote/hybrid options

Professional growth opportunities

Competitive salary

Job summary

Fortrea is seeking a Site Start-Up Specialist to coordinate site start-up activities, manage essential documents, and ensure regulatory submissions are completed efficiently. The role involves serving as the primary contact for investigative sites during start-up and maintenance, and collaborating with sponsors and regulatory authorities to ensure timely, compliant processes.

In this remote-friendly position, you will support cross-functional teams, maintain audit-ready documentation, and

Qualifications

• University/College degree (life sciences preferred) or certification in a related allied health profession.
• Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.
• Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
• Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.
• Experience interacting with regulatory authorities and site start-up teams.
• Excellent organizational, problem-solving, and communication skills.
• Proficiency in Microsoft Office and document management systems.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Responsibilities

• Serve as the primary contact for investigative sites during start-up and maintenance activities.
• Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
• Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
• Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
• Track submission timelines and proactively address potential delays.
• Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
• Ensure all documentation is audit-ready and systems are consistently updated.
• Assist in the negotiation of site contracts and budgets, if applicable.
• Provide mentorship and training to new hires and less-experienced colleagues.

Skills

ICH/GCP guidelines

Regulatory submissions

Site activation

Documentation management

Microsoft Office

Education

University/College degree (life sciences)

Tools

Document management systems

Job description

Fortrea is seeking a Site Start-Up Specialist to coordinate site start-up activities, manage essential documents, and ensure regulatory submissions are completed efficiently. The role involves serving as the primary contact for investigative sites during start-up and maintenance, and collaborating with sponsors and regulatory authorities to ensure timely, compliant processes.

In this remote-friendly position, you will support cross-functional teams, maintain audit-ready documentation, and