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Precision Medicine Group helps pharmaceutical and life sciences organizations develop and commercialize products by bringing together expertise in precision medicine, laboratory science, translational informatics, regulatory affairs, payer insights, and marketing communications. Its work spans biomarker-driven research and development, clinical and commercial strategy, and support across the product lifecycle, from launch through maturity. The company operates through Precision for Medicine, which focuses on clinical solutions, and Precision AQ, which provides commercial solutions for life sciences clients.
Regulatory and Site Start-Up Specialist (Australia, Remote)
Support clinical trial submissions, essential documentation, and site activation for Precision Medicine Group, a life sciences CRO. Coordinate Australian study start-up activities while maintaining regulatory compliance and operational readiness.
Description
- Ensure timely, high-quality site activation readiness for assigned countries and sites while identifying and reducing risks
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies
- Liaise with Competent Authorities and Ethics Committees and manage their responses
- Provide consistent submission updates to Start-Up and Regulatory Leads, Project Managers, and project teams
- Keep project plans, trackers, and regulatory intelligence systems accurate and current
- Help develop study-specific start-up plans, IMP release requirements, and essential document review criteria
- Work with site CRAs to coordinate communications and obtain site collaboration
- Prepare, review, and manage essential documents required for site activation and IMP release
- Adapt country- and site-specific Patient Information Sheets and Informed Consent Forms
- Coordinate the translation of study documents
- Collaborate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
- Track site activation critical-path information, including authority and IRB/EC timelines, contracts, and budget negotiation requirements
- Assist with study budget negotiations and investigator contract execution when needed
- Support feasibility outreach to potential sites as required
- Stay current on local clinical trial laws and regulations and share regulatory knowledge internally
- Maintain audit and inspection readiness and file documents in line with TMF and study-specific plans
- Assist with Pre-Study Site Visits, process improvement, training, and mentoring
- Carry out additional responsibilities assigned by management
Requirements
- Bachelor’s degree in life sciences or a related discipline, Registered Nurse qualification, or an equivalent combination of education, training, and experience
- At least one year of experience as a Regulatory or Site Start-Up Specialist, or in a comparable CRO, pharmaceutical, or biotechnology role, with equivalent relevant experience or demonstrated competencies also considered
- Strong communication and organizational abilities
- Proficiency with computerized information systems, electronic spreadsheets, word processing software, and email
- Fluency in English and, where applicable, the local language of the country in which the position is based
- Legal authorization to work in the country of employment without employer sponsorship
- Country-specific regulatory and site start-up experience preferred
- Familiarity with milestone tracking tools or systems preferred
- Ability to prioritize work and meet deadlines preferred
- An advanced medical or life sciences degree, RAC certification, or Master’s in Regulatory Science preferred
Benefits
- Regular full-time employment status
- Equal opportunity employment
- Reasonable accommodation available during the application process
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