Regulatory and Site Start-Up Specialist
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Job Description
Regulatory and Site Start-Up Specialist supporting clinical trial submissions, site activation, and essential documents. Precision for Medicine integrates clinical operations, scientific expertise, laboratories, and data sciences.
Responsibilities:
- Deliver timely and high-quality site activation readiness within assigned country/sites and foresee and mitigate risks
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies
- Interact with Competent Authorities and Ethics Committees and handle responses
- Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams
- Maintain project plans, trackers, and regulatory intelligence tools
- Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria
- Partner with site CRAs to align communication and secure site collaboration
- Prepare, review, and manage essential documents for site activation and IMP release
- Customize country/site-specific Patient Information Sheets and Informed Consent Forms
- Facilitate document translations and coordinate translations required for submissions
- Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
- Act as subject matter expert for site activation critical-path data, including regulatory timelines, contracts, budgets, and required reviews
- Support study budget negotiations and investigator contract execution when required
- Support feasibility activities and site outreach when needed
- Maintain knowledge of local clinical trial laws and regulations and distribute knowledge within Precision for Medicine
- Maintain audit/inspection readiness and file documents according to TMF and study-specific plans
- Support Pre-Study Site Visits, process improvement initiatives, training, and mentoring
- Perform other duties assigned by management
Requirements:
- 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 Site Start-Up Specialist, or comparable role, in 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 and, for non-English-speaking countries, the local language of the country where the position is based
- Relevant regulatory and site start-up experience for the particular country preferred
- Experience using milestone tracking tools/systems preferred
- Ability to prioritize workload to meet deadlines preferred
- Advanced degree in medical or life sciences, MD, PhD, PharmD, RAC certification, or Master’s in Regulatory Science preferred
Benefits:
- Regular full-time employment
- Remote work arrangement
- Equal opportunity employer
- Reasonable accommodation for applicants with disabilities
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