Regulatory and Site Start Up Specialist

TL;DR

Regulatory and Site Start Up Specialist (Clinical Trials): Delivery of site activation readiness including preparation of clinical trial application forms, submission dossiers, and interactions with Competent Authorities and Ethics Committees with an accent on compliance with ICH-GCP and local regulations. Focus on mitigating risks, managing essential documents, and ensuring timely authorizations for trial conduct.

Remote, Australia

Company

Precision for Medicine is a Clinical Research Organization specializing in precision medicine, oncology, rare diseases, and other therapeutic areas with integrated clinical trial designs and biomarker analytics.

What you will do

• Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, and local bodies to obtain trial authorizations.
• Interact with CA/EC, handle responses, and provide updates to Start Up Lead, Regulatory Lead, and Project Team.
• Maintain project plans, trackers, and regulatory intelligence tools; develop study-specific start-up plans and IMP release requirements.
• Partner with site CRA for essential document collection, customize Patient Information Sheets and Informed Consent Forms, and facilitate translations.
• Act as SME for site activation critical path data, support budget negotiations and contracts, and maintain audit/inspection readiness in TMF.
• Support feasibility assessments, pre-study site visits, and knowledge sharing on local clinical trial regulations.

Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse, or equivalent; Pharmacy qualification highly beneficial.
• 1+ year as Regulatory or Start Up specialist in CRO/pharma/biotech or equivalent experience.
• Fluency in English.
• Strong communication and organizational skills; experience with computerized systems, spreadsheets, word processing, and email.

Nice to have

• Relevant experience in regulatory submissions, feasibility, contract negotiations.
• Experience with milestone tracking tools/systems.
• Ability to prioritize workload; advanced degree (MD, PhD, PharmD), RAC certification, or Masters in Regulatory Science.

Culture & Benefits

• Growing organization valuing employee contributions and ideas for positive change.
• Opportunity to work on groundbreaking cancer therapies and rare diseases research.
• Equal Opportunity Employer committed to diversity and inclusion.