Regulatory And Start Up Specialist (Clinical Research)

Location: Home-based role in Romania; Romanian language skills required

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Act as the single point of contact for investigative sites, Site Activation Managers, project management, and other departments.
• Perform country-level start-up and site activation activities in line with regulations, SOPs, work instructions, and project requirements.
• Prepare, review, distribute, and quality-control regulatory, ethics, informed consent, and Investigator Pack documents.
• Track document approvals, execution, releases, site progress, project timelines, and internal study records.
• Provide local expertise for project planning, site performance reviews, monitoring measures, and contingency planning.
• Communicate completion of regulatory and contractual documents and support sponsors on specific initiatives.

Requirements

• Romanian language skills required.
• Ability to perform site activation and regulatory activities according to applicable local and international regulations.
• Experience or capability in preparing and reviewing site regulatory documents for completeness and accuracy.
• Ability to maintain databases, tracking tools, and project-specific information accurately.
• Ability to coordinate with investigative sites, project teams, and sponsors while meeting project timelines.

Culture & Benefits

• Home-based work arrangement.
• Work within a global clinical research and healthcare intelligence organization.
• Role governed by established SOPs, work instructions, quality standards, and project procedures.
• Full-time employment.