Regulatory and Site Start-Up Specialist

🔥 15 hours ago

🇰🇷 South Korea – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

👻 Ghost score 10%

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Deliver timely and high-quality site activation readiness within assigned country/sites and foresee and mitigate risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams • Maintain project plans, trackers, and regulatory intelligence tools • Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with site CRAs to align communication and secure site collaboration • Prepare, review, and manage essential documents for site activation and IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Facilitate document translations and coordinate translations required for submissions • Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams • Act as subject matter expert for site activation critical-path data, including regulatory timelines, contracts, budgets, and required reviews • Support study budget negotiations and investigator contract execution when required • Support feasibility activities and site outreach when needed • Maintain knowledge of local clinical trial laws and regulations and distribute knowledge within Precision for Medicine • Maintain audit/inspection readiness and file documents according to TMF and study-specific plans • Support Pre-Study Site Visits, process improvement initiatives, training, and mentoring • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree in life sciences or related field, ideally in a scientific or healthcare discipline, or Registered Nurse (RN), or equivalent combination of education, training, and experience • 1 year or more as a Regulatory or Site Start-Up Specialist, or comparable role, in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Strong communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based • Relevant regulatory and site start-up experience for the particular country preferred • Experience using milestone tracking tools/systems preferred • Ability to prioritize workload to meet deadlines preferred • Advanced degree in medical or life sciences, MD, PhD, PharmD, RAC certification, or Master’s in Regulatory Science preferred

🏖️ Benefits

• Regular full-time employment • Remote work arrangement • Equal opportunity employer • Reasonable accommodation for applicants with disabilities