Regulatory and Site Start Up Specialist

TL;DR

Regulatory and Site Start Up Specialist (Clinical Research): Delivery of site activation readiness and preparation of clinical trial application forms and submission dossiers for Competent Authorities and Ethics Committees with an accent on compliance with local regulations, ICH-GCP, and timelines. Focus on interacting with CA/EC, managing essential documents collection, customizing consent forms, and mitigating risks for timely site activation.

Remote, South Korea

Company

Precision for Medicine is a Clinical Research Organization enabling precision medicine through integrated clinical trial designs, operational expertise, biomarker analytics, with focus on rare diseases and oncology.

What you will do

• Prepare clinical trial applications, submission dossiers, and handle CA/EC interactions and responses.
• Provide updates on submissions to Start Up Lead, Regulatory Lead, and Project Team; maintain project plans and trackers.
• Develop study-specific start-up plans, IMP release requirements, and essential document review criteria.
• Partner with site CRA for essential documents collection, customize Patient Information Sheets and ICFs, facilitate translations.
• Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.
• Act as SME for site activation critical path data, support budget negotiations and feasibility outreach when required.

Requirements

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

Nice to have

• Qualification or experience as Pharmacist.
• Relevant experience in regulatory submissions, feasibility, contract negotiations.
• Experience with milestone tracking tools.
• Advanced degree (MD, PhD, PharmD), RAC certification, Masters in Regulatory Science.

Culture & Benefits

• Growing organization focused on groundbreaking cancer therapies and precision medicine.
• Employees' contributions and ideas valued, impacting positive change.
• Equal Opportunity Employer committed to diversity and inclusion.