Regulatory and Site Start Up Specialist
Remote
Job Summary
Deliver site activation readiness within assigned countries by preparing Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees. Manage interactions with regulatory bodies, maintain project trackers, and customize Patient Information Sheets and Informed Consent Forms. Partner with site CRAs to secure document collection, coordinate translations, and act as subject matter expert for critical path data points including contract negotiations and budget requirements. Ensure audit readiness, support feasibility site outreach, and maintain updated knowledge of local clinical trial laws. Maintain communication with Feasibility, Clinical Operations, and Project Management teams to track deliverables and secure on-time site activation.
Required Qualifications
- 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 SU specialist (or comparable role) in either 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
Desired Qualifications
- A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial
- Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience
- Experience using milestone tracking tools/systems
- Ability to prioritize workload to meet deadlines
- Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science
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