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Contact Info
Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
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Details

Clinical Trial Start Up Associate, Native Romanian


Reference:POR/048781 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Research Associate

This role requires Native Romanian & Fluent


A Romanian speaking Trial Capabilities Associate is required to join a leading global pharmaceutical business based in Cork. This is an opportunity to join a vibrant multi-cultural and multi-lingual team where you will play your part in making a difference for people the world over by supporting the business as it discovers, develops, and delivers medicines that help people live longer, healthier and more active lives.

The role

  • Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
  • Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
  • Identify, communicate, and resolve issues
  • Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
  • Leverage previous site / review board engagements to efficiently drive new work
  • Populate internal systems to ensure accuracy of trial / site performance

The Person

  • Bachelor’s degree preferably in a scientific or health related field
  • 5+ years clinical research/clinical operations experience or relevant experience preferred
  • Native Romanian & fluent English required for this role
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation
  • Applied knowledge of project management processes and skills

For further details please contact; Paula O’Reilly on 00 353 (0)87 7094141 or send CV in confidence to [email protected]

A Romanian speaking Trial Capabilities Associateis required to join a leading global pharmaceutical business based in Cork. This is an opportunity to join a vibrant multi-cultural and multi-lingual team where you will play your part in making a difference for people the world over by supporting the business as it discovers, develops, and delivers medicines that help people live longer, healthier and more active lives.

The role

Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities

Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out

Identify, communicate, and resolve issues

Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems

Leverage previous site / review board engagements to efficiently drive new work

Populate internal systems to ensure accuracy of trial / site performance

The Person

Bachelor’s degree preferably in a scientific or health related field

5+ years clinical research/clinical operations experience or relevant experience preferred

Native Romanian & fluent English required for this role

Understanding of the overall clinical development paradigm and the importance of efficient site initiation

Applied knowledge of project management processes and skills

For further details please contact; Paula O’Reilly on 00 353 (0)87 7094141 or send CV in confidence to [email protected]