SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Precision for Medicine is a Clinical Research Organization specializing in precision medicine, rare diseases, and oncology. They combine novel clinical trial designs, operational expertise, biomarker analytics, and data solutions to advance clinical research.
You will join as a Regulatory and Site Start-Up Specialist, responsible for ensuring timely and quality site activation readiness across assigned countries and sites while identifying and mitigating risks.
Key responsibilities include:
- Prepare Clinical Trial Application Forms and submission dossiers (initial and amendments) for Competent Authorities, Ethics Committees, and other local bodies per local requirements and timelines
- Interact with regulatory and ethics bodies, handle their responses, and provide regular updates to leadership and project teams
- Maintain project plans, trackers, and regulatory intelligence tools; keep Regulatory Leadership informed
- Develop study-specific start-up plans, IMP release requirements, and essential document review criteria
- Partner with site Clinical Research Associates to ensure alignment and secure site review and collection of essential documents for site activation/IMP release
- Customize country/site-specific Patient Information Sheets and Informed Consent Forms
- Manage translation coordination for regulatory documents
- Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams on project status and deliverables
- Act as subject matter expert for site-level critical path data, including Competent Authority and Ethics Committee timelines, site contracts, and budget negotiations
- Participate in study budget negotiations and investigator contract execution under Site Contract Management direction
- Support feasibility team in site outreach and investigator interest assessment
- Maintain current knowledge of local clinical trial laws and regulations; distribute knowledge within the organization
- Maintain audit/inspection readiness and file documents per Trial Master File plans
- May support clinical team during Pre-Study Site Visits
Requirements:
- Bachelor's degree in life sciences or related field (scientific or healthcare discipline), or Registered Nurse (RN), or equivalent education/training/experience
- Pharmacy qualification or pharmacist work experience highly beneficial
- Minimum 1 year as Regulatory or Site Start-Up Specialist (or comparable role) in a CRO, pharmaceutical, or biotech industry, or equivalent relevant experience and demonstrated competencies
- Strong communication and organizational skills
- Experience with computerized information systems, electronic spreadsheets, word processing, and email
- Fluency in English
- Preferred: relevant regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions); experience with milestone tracking tools/systems; ability to prioritize workload to meet deadlines; advanced degree (MD, PhD, PharmD) or RAC certification or Masters in Regulatory Science
