Regulatory and Site Start Up Specialist

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

📋 Description

• Accountable for ensuring the timely and quality delivery of site activation readiness within the designated country/sites while anticipating and addressing any potential risks.

• Responsible for the preparation of Clinical Trial Application Forms and the compilation of submission dossiers (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other relevant local bodies in accordance with local requirements and required timelines to secure all necessary authorizations/approvals for conducting the Clinical Trial as per international and local/national regulations, company SOPs, and ICH-GCP principles.

• Engage with Competent Authorities/Ethics Committees for study-related purposes and manage responses delivered to them.

• Regularly update the Start Up Lead and/or Regulatory Lead assigned to the study, as well as the Project Manager/Project Team, on the status of CA and EC submissions.

• Maintain project plans, project trackers, and regulatory intelligence tools related to assigned responsibilities while keeping Regulatory Leadership informed.

• Prepare and support the development of study-specific start-up plans, IMP release requirements, and criteria for essential document review.

• Collaborate with the assigned site CRA to ensure consistent communication and facilitate site reviews while managing the collection of essential documents needed for site activation/IMP release.

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

• Oversee and coordinate the translation of documents as needed.

• Maintain communication with other key functions involved in country start-up, such as Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management groups, regarding project-specific status and deliverables.

• Act as a Subject Matter Expert in collecting and maintaining site-level critical path data points for Site Activation, including but not limited to timelines for Competent Authorities, local IRB/Ethics Committee (EC), site contracts, and budget negotiation requirements, to ensure timely site activation for the assigned sites in the country.

• When necessary, participate in and support the negotiation of study budgets and the execution of investigator contracts under the guidance of the Site Contract Management department or designated department.

• May assist the feasibility group in reaching out to sites to evaluate the potential interest of investigators in a prospective study.

• Stay informed about local clinical trial laws and regulations, and aid in disseminating this knowledge within PFM to ensure Clinical Trials are conducted in accordance with both international and local/national applicable regulations.

• Maintain audit/inspection readiness at all times and file documents according to the TMF plan and/or specific study plans in the appropriate TMF.

• May support the clinical team in conducting Pre-Study Site Visits.

⛳️ Requirements

• Bachelor's degree in life sciences or a related field (preferably in a scientific or healthcare discipline), or a Registered Nurse (RN) or a similar combination of education, training, and experience.

• A qualification in Pharmacy or experience working as a Pharmacist is highly advantageous.

• At least 1 year of experience as a Regulatory or Start-Up specialist (or in a similar 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.

• Proficient in English.

🏝️ Benefits

• Precision for Medicine is a Clinical Research Organization.

• Opportunities for professional development.

• Participation in global team events.