Responsible for delivery, in terms of timeliness and quality, of site activation readiness
Preparation of Clinical Trial Application Forms and submission dossiers
Interaction with Competent Authorities and Ethics Committees
Providing updates about submissions to team leads
Maintenance of project plans and regulatory intelligence tools
Preparation/support the development of startup plans
Partner with site CRA for communication and document collection
Customize country/site specific Patient Information Sheet and Informed Consent Form
Maintain communication with key functions on project status
Assist in collection and maintenance of critical path data points
May support negotiation of study budgets
Keep updated knowledge of local clinical trial laws and regulations
Maintain audit/inspection readiness

Bachelor’s degree in life sciences or related field, or Registered Nurse (RN)
A qualification in Pharmacy/work experience as a Pharmacist would be beneficial
1 year or more as a Regulatory or SU specialist (or comparable role) in 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 required
Fluency in English

Regulatory and Site Start Up

Key skills