Regulatory and Site Start Up Specialist

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

📋 Description

• Accountable for ensuring timely and high-quality site activation readiness within the designated country/sites while anticipating and mitigating any potential risks.

• Preparation of Clinical Trial Application Forms and the compilation of submission dossiers (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other relevant local entities in accordance with local requirements and mandated timelines to secure all necessary authorizations/approvals for conducting Clinical Trials in compliance with international and local/national regulations, company SOPs, and ICH-GCP principles.

• Engage with Competent Authorities/ Ethics Committees for study-related purposes and manage responses directed to them.

• Provide regular updates regarding Competent Authority and Ethics Committee submissions to the Start Up Lead and/or Regulatory Lead assigned to the study, as well as to the Project Manager/Project Team.

• Maintain project plans, trackers, and regulatory intelligence tools relevant to assigned duties, keeping Regulatory Leadership informed.

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

• Collaborate with the assigned site Clinical Research Associate (CRA) to ensure effective communication and oversee the collection of essential documents necessary for site activation/IMP release.

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

• Oversee and coordinate the translation of documents as necessary.

• Maintain communication with other key departments involved in country start-up, including Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management groups, regarding project-specific status and deliverables.

• Serve as a Subject Matter Expert (SME) for the collection and maintenance of site-level critical path data points related to Site Activation, including but not limited to timelines for Competent Authority, local IRB/Ethics Committee (EC), site contracts, and budget negotiations, ensuring on-time site activation for assigned sites in the region.

• When necessary, assist in the negotiation of study budgets and the execution of investigator contracts under the guidance of the Site Contract Management department or designated personnel.

• Potentially participate in supporting the feasibility group in outreach to gauge investigator interest in a prospective study.

• Stay informed on local clinical trial laws and regulations, disseminating this knowledge within PFM to ensure conduct of Clinical Trials aligns with international and local/national regulations.

• Maintain audit/inspection readiness consistently and organize documents according to the Trial Master File (TMF) plan or study-specific plans in the appropriate TMF.

• May support the clinical team in executing Pre-Study Site Visits.

⛳️ Requirements

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

• A qualification in Pharmacy or experience working as a Pharmacist would be advantageous.

• At least 1 year of experience as a Regulatory or Start-Up specialist (or similar role) in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Excellent communication and organizational abilities.

• Proficiency in using computerized information systems, electronic spreadsheets, word processing, and electronic mail is required.

• Fluent in English.

🏝️ Benefits

• Competitive salary

• Opportunities for professional development

• Flexible work arrangements