Regulatory and Site Start-Up Specialist

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

📋 Description

• Ensure timely and high-quality readiness for site activation within assigned countries/sites while anticipating 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 and Project Managers/Project Teams.

• Maintain project plans, trackers, and regulatory intelligence tools to support operations.

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

• Collaborate with site CRAs to ensure effective communication and foster site collaboration.

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

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

• Facilitate document translations and coordinate necessary translations for submissions.

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

• Serve as a subject matter expert on critical-path data for site activation, including regulatory timelines, contracts, budgets, and required reviews.

• Support study budget negotiations and execution of investigator contracts when necessary.

• Assist with feasibility activities and site outreach as required.

• Stay informed about local clinical trial laws and regulations, sharing knowledge within Precision for Medicine.

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

• Support Pre-Study Site Visits, process improvement initiatives, training, and mentoring efforts.

• Perform additional duties as assigned by management.

⛳️ 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.

• At least 1 year of experience as a Regulatory or Site Start-Up Specialist, or in a comparable role within a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Excellent communication and organizational skills.

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

• Fluency in English, and for non-English-speaking countries, proficiency in the local language of the country where the position is based.

• Relevant regulatory and site start-up experience in the specific country is preferred.

• Experience with milestone tracking tools/systems is preferred.

• Ability to prioritize workload effectively to meet deadlines is preferred.

• An advanced degree in medical or life sciences, MD, PhD, PharmD, RAC certification, or a Master’s in Regulatory Science is preferred.

🏝️ Benefits

• Regular full-time employment.

• Remote work arrangement available.

• Equal opportunity employer.

• Reasonable accommodations for applicants with disabilities.