Regulatory and Site Start-Up Specialist

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

📋 Description

• Ensure prompt and high-quality site activation readiness across designated countries/sites while proactively identifying and addressing potential risks.

• Draft Clinical Trial Application Forms and submission packages for Competent Authorities, Ethics Committees, IRBs, and other relevant local entities.

• Engage with Competent Authorities and Ethics Committees, managing their responses effectively.

• Provide regular updates on submissions to Start Up/Regulatory Leads and Project Managers/Project Teams.

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

• Assist with study-specific start-up plans, IMP release requirements, and essential document review criteria.

• Collaborate with assigned site CRAs to align communication strategies and foster site cooperation.

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

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

• Facilitate the translation of documents and manage translation activities effectively.

• Coordinate efforts with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.

• Serve as a subject matter expert for site-level critical paths and Site Activation data points.

• Assist with study budget negotiations and the execution of investigator contracts when necessary.

• Support feasibility site outreach as needed.

• Keep abreast of local clinical trial laws and regulations, sharing knowledge within Precision for Medicine.

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

• Assist with Pre-Study Site Visits as needed.

• Contribute to process improvement initiatives, training, and mentoring activities.

• Carry out additional responsibilities 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 as a Regulatory or Start-Up specialist (or similar role) in a CRO or the pharmaceutical/biotech industry, or relevant experience and/or demonstrated competencies.

• Strong communication and organizational skills are crucial.

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

• Fluency in English, and for positions in non-English speaking countries, proficiency in the local language is necessary.

• Preferred experience in relevant regulatory and site start-up activities (feasibility, contract negotiations, CA/EC/IRB submissions) specific to the country.

• Experience with milestone tracking tools/systems is preferred.

• Ability to prioritize tasks 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

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.

• AI-generated insights provided during the application process, including resume reviews and interviews, with the option to opt-out.