Regulatory and Site Start Up Specialist

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

📋 Description

• Ensure timely and high-quality site activation readiness across designated countries/sites while identifying and addressing potential risks.

• Prepare Clinical Trial Application forms and submission packages for Competent Authorities, Ethics Committees, IRBs, and other relevant local organizations.

• Engage with Competent Authorities and Ethics Committees, managing responses effectively.

• Provide consistent submission updates to Start Up/Regulatory Leads as well as Project Managers/Project Teams.

• Maintain project timelines, trackers, and regulatory intelligence tools.

• Assist in the development of study-specific start-up plans, IMP release requirements, and criteria for essential document reviews.

• Collaborate with assigned site CRAs to ensure effective communication and secure collaboration from sites.

• Prepare, review, and organize essential documents necessary for site activation and IMP release.

• Tailor country/site-specific Patient Information Sheets and Informed Consent Forms.

• Coordinate document translations and manage translation activities.

• Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.

• Serve as a subject matter expert on site-level critical-path and site activation data points.

• Assist with study budget negotiations and the execution of investigator contracts as needed.

• Support feasibility site outreach when required.

• Stay up-to-date with local clinical trial laws and regulations, disseminating knowledge within the organization.

• Ensure audit/inspection readiness and organize documents following TMF and study-specific plans.

• Provide support for Pre-Study Site Visits when necessary.

• Contribute to process improvement initiatives, training, and mentorship.

• Perform other duties as assigned by management.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field, or a Registered Nurse (RN), or an equivalent combination of education, training, and experience.

• Minimum of 1 year in a Regulatory or Site Start-Up specialist role, or a similar position within a CRO, pharmaceutical, or biotech company, or equivalent relevant experience and/or proven competencies.

• Excellent communication and organizational abilities.

• Proficient in using computerized information systems, electronic spreadsheets, word processing, and email.

• Fluency in English and, for roles in non-English-speaking countries, proficiency in the local language of the respective country.

• Candidates must have legal authorization to work in the country of employment without employer sponsorship.

• Preferred: relevant regulatory and site start-up experience specific to the country.

• Preferred: experience with milestone tracking tools/systems.

• Preferred: capability to prioritize tasks effectively to meet deadlines.

• Preferred: advanced degree in medical or life sciences, RAC certification, or a Master’s in Regulatory Science.

🏝️ Benefits

• Regular full-time employment.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.