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Precision for Medicine is a global Clinical Research Organization specializing in precision medicine, combining novel clinical trial designs, operational expertise, biomarker analytics, and a focus on rare diseases and oncology.
You will join as a Regulatory and Start-Up Specialist based in the UK, responsible for delivering site activation readiness across assigned countries and sites. Your core responsibilities include:
• Preparing Clinical Trial Application Forms and submission dossiers (initial and amendments) for Competent Authorities, Ethics Committees, and local bodies per local requirements and ICH-GCP principles
• Interacting with regulatory and ethics bodies, handling their responses and maintaining regular updates to leadership and project teams
• Maintaining project plans, trackers, and regulatory intelligence tools
• Developing study-specific start-up plans, IMP release requirements, and essential document review criteria
• Partnering with site Clinical Research Associates to ensure aligned communication and secure site activation
• Reviewing and managing collection of essential documents for site activation and IMP release
• Customizing country/site-specific Patient Information Sheets and Informed Consent Forms
• Coordinating document translations and managing translation workflows
• Communicating with cross-functional teams (Feasibility, Clinical Operations, Project Management, Site Contracts) on project status
• Acting as subject matter expert for site-level critical path data, including regulatory timelines, site contracts, and budget negotiation requirements
• Supporting negotiation of study budgets and execution of investigator contracts under Site Contract Management direction
• Supporting feasibility activities in site outreach and investigator engagement
• Maintaining current knowledge of local clinical trial laws and regulations, distributing expertise across the organization
• Ensuring audit/inspection readiness and proper TMF filing
• Supporting pre-study site visits as needed
REQUIREMENTS:
Minimum Required:
• Bachelor's degree in life sciences or related field (scientific or healthcare discipline), or Registered Nurse (RN), or equivalent education/training/experience
• Pharmacy qualification or pharmacist work experience highly beneficial
• At least 2 years of relevant experience
Other Required:
• Previous experience as a Regulatory and Start-Up Specialist, Site Contracts Specialist in a CRO, pharmaceutical, or biotech industry, or equivalent relevant experience and demonstrated competencies
• Strong communication and organizational skills
• Experience with computerized information systems, electronic spreadsheets, word processing, and email
• Fluency in English
Preferred:
• Relevant regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions)
• Site contract and budget negotiation experience
• Experience with milestone tracking tools/systems
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or Masters in Regulatory Science
• Must be legally authorized to work in the UK without employer sponsorship
