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Precision for Medicine is a clinical research organization (CRO) that combines advanced technologies, scientific expertise, and operational scale to accelerate the development and approval of life-changing therapies. The company specializes in oncology and rare disease clinical trials, integrating clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.
The Regulatory and Site Start-Up Specialist (RSS) is an experienced professional responsible for regulatory submissions and site activation activities in an assigned country or region. This role bridges regulatory compliance with operational site readiness, ensuring timely and high-quality clinical trial approvals and site activation.
Key Responsibilities:
• Prepare and submit clinical trial applications and regulatory dossiers (initial and amendments) to Competent Authorities, Ethics Committees/IRBs, and other local bodies according to local requirements and international regulations (ICH-GCP).
• Manage interactions with regulatory and ethics authorities, including handling responses and providing status updates to leadership and project teams.
• Ensure site activation readiness within assigned country/sites, identifying and mitigating risks to timelines and quality.
• Develop and maintain study-specific start-up plans, IMP release requirements, and essential document review criteria.
• Prepare, review, and manage collection of essential documents required for site activation and IMP release.
• Customize and manage Patient Information Sheets and Informed Consent Forms for country/site-specific requirements.
• Coordinate translations of regulatory and study documents.
• Act as subject matter expert on local clinical trial laws and regulations, advising internal teams (CRAs, Clinical Operations, Project Management, Site Contracts).
• Maintain critical path data for site activation, including regulatory timelines, ethics committee approvals, contract execution, and budget negotiations.
• Support site contract negotiations and investigator contract execution under Site Contract Management direction.
• Participate in feasibility assessments and pre-study site visits as needed.
• Maintain audit and inspection readiness; file documents according to Trial Master File (TMF) plans.
• Support process improvement initiatives, training, and mentoring.
Requirements:
• Bachelor's degree in life sciences or related field (scientific or healthcare discipline), or Registered Nurse (RN) credential, or equivalent combination of education, training, and experience.
• Minimum 1 year of experience as a Regulatory or Site Start-Up Specialist (or comparable role) in a CRO, pharmaceutical, or biotech company, or equivalent relevant experience and demonstrated competencies.
• Strong communication and organizational skills.
• Proficiency with computerized information systems, electronic spreadsheets, word processing, and email.
• Fluency in English; fluency in the local language of the assigned country is required.
Preferred Qualifications:
• Relevant regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions) for the specific country.
• Experience with milestone tracking tools and systems.
• Ability to prioritize workload and meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or Master's in Regulatory Science.
