Regulatory and Site Start Up Specialist

New

Precision Medicine GroupClinical Research Organization

Remote, South KoreaFull-TimeMiddle

Salary not disclosed

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Job Details

Languages: English
Experience: 1 year or more as a Regulatory or SU specialist

Requirements

Bachelor’s degree in life sciences, healthcare, or Registered Nurse (RN).
Minimum 1 year of experience as a Regulatory or Site Start Up specialist.
Experience in a CRO or pharmaceutical/biotech industry.
Strong communication and organizational skills.
Proficiency in computerized information systems, electronic spreadsheets, and word processing.
Fluency in English.
Ability to prioritize workload to meet deadlines.

Responsibilities

Deliver site activation readiness for assigned country/sites.
Prepare Clinical Trial Application Forms and submission dossiers.
Handle interactions and responses for CAs/ECs.
Maintain project plans and regulatory intelligence tools.
Support study specific start-up plans and document review criteria.
Manage collection of essential documents for site activation.
Customize country/site specific Patient Information Sheets and Informed Consent Forms.
Facilitate document translation and coordination.
Maintain audit and inspection readiness for the TMF.

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