Regulatory and Site Start Up Specialist (Clinical Trials)

Location: Remote, Australia. Candidates must be legally authorized to work in Australia without employer sponsorship.

Company

hirify.global is a contract research organization integrating clinical trial execution with scientific, laboratory, and advanced data science expertise, with a focus on oncology and rare disease.

What you will do

• Manage site activation readiness, timelines, quality, and risk mitigation for assigned clinical trial sites in Australia.
• Prepare and submit clinical trial applications, amendments, notifications, and submission dossiers to competent authorities, ethics committees, IRBs, and other applicable bodies.
• Interact with regulatory authorities and ethics committees, manage responses, and provide submission status updates to study leadership and project teams.
• Collect, review, maintain, and file essential documents required for site activation, IMP release, audit readiness, and the Trial Master File.
• Customize patient information sheets and informed consent forms, and coordinate required translations.
• Coordinate with CRAs, clinical operations, feasibility, project management, regulatory, and site contract teams; support budget and investigator contract negotiations when required.

Requirements

• Bachelor’s degree in life sciences or a related field, or Registered Nurse qualification, or an equivalent combination of education, training, and experience.
• At least 1 year of experience as a regulatory or site start-up specialist, or in a comparable CRO, pharmaceutical, or biotechnology role.
• Strong communication and organizational skills with the ability to prioritize work and meet deadlines.
• Experience with computerized information systems, spreadsheets, word processing, and email.
• Fluent English and the local language of the country where the position is based are required for non-English-speaking countries.
• Legal authorization to work in Australia without employer sponsorship is required.

Nice to have

• Country-specific experience with regulatory submissions, feasibility, site start-up, contract negotiations, and competent authority or ethics committee interactions.
• Experience with milestone tracking tools and systems.
• Advanced degree in medicine or life sciences, RAC certification, or a master’s degree in regulatory science.

Culture & Benefits

• Remote work arrangement based in Australia.
• Opportunity to support clinical trials focused on oncology and rare disease.
• Collaboration across regulatory, clinical operations, feasibility, project management, and site contract functions.
• Opportunities to contribute to process improvement, training, and mentoring.