Site Start-Up Specialist

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Act as the main point of contact for investigative sites throughout start-up and ongoing maintenance activities.

• Gather, assess, and organize vital documents necessary for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).

• Ensure adherence to ICH/GCP guidelines, regulatory standards, and sponsor requirements.

• Prepare and submit regulatory documentation, including country-specific application forms and informed consent forms.

• Monitor submission timelines and proactively manage potential delays.

• Collaborate with both internal and external stakeholders, including vendors, clinical teams, and regulatory entities.

• Ensure all documentation is ready for audits and that systems are regularly updated.

• Assist in negotiating site contracts and budgets, if required.

• Provide mentorship and training to new employees and less experienced colleagues.

⛳️ Requirements

• University/College degree (preferably in life sciences) or certification in a relevant allied health profession.

• At least 2 years of experience in clinical research, regulatory submissions, or site activation.

• Strong understanding of ICH/GCP guidelines, regulatory affairs, IRB/IEC regulations, and start-up processes.

• Capability to review and modify patient informed consent forms to comply with local and protocol-specific requirements.

• Background in engaging with regulatory authorities and site start-up teams.

• Exceptional organizational, problem-solving, and communication abilities.

• Proficiency in Microsoft Office and document management systems.

🏝️ Benefits

• Competitive salary along with performance-based incentives.

• Flexible work arrangements, including remote/hybrid options.

• Opportunities for professional growth in a collaborative and innovative environment.

• The chance to engage in cutting-edge clinical research projects.