Clinical Affairs Associate

Sofia Bio/ Discovery Life Science is looking for Clinical Affairs Associate to join our team in Bucharest, Romania. The Clinical Affairs Associate, contributes to our mission by assisting with site coordination and collection of biological materials. This position provides dedicated, knowledgeable support focused on proper project completion.

Responsibilities include:

• Prepares and facilitates site training and initiation
• Conducts all types of monitoring, including but not limited to routine monitoring, close out and audit visit attendance
• Verifies clinical data against source documentation during routine monitoring
• Ensures study documentation maintenance is up to date on-site and in-house
• Completes project specific data in DLS software system
• Assists in coordinating logistic activities related to collection of biological material, packaging and shipping to client
• Assists in logistic activities related to project supply management
• May need to work under supervision
• Translates study documents, as required
• Collects and submits regulatory documentation to the Competent Authority / Ethics Committee

Education and Experience Requirements:

• University/college degree in medicine, pharmacy, biology, life science preferred
• Previous experience in administrative work preferable
• Good written and oral communication skills
• Excellent organizational and time management skills
• Fluent in written and verbal English
• Ability to work well within a team
• Computer competency

  
Interested candidates should submit a CV and a cover letter in English by end of February, short listed candidates will be contacted for this ongoing search.