Senior Clinical Operations Assistant

Due to a growing portfolio, we are currently looking for an experienced Clinical Operations Assistants to be based inRomania - Bucharest .

This is a great opportunity for someone looking to to progress to a Clinical Research Associate role in the future.

The role of the Clinical Operations Assistant (COA) is to maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality.

Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case Report Forms to clients for assigned projects, upload and naming of documents to the electronic document management system, EDC User Management activities and activities associated with Impact Harmony, as appropriate.

COA is also to support all site management team members on local billable administrative tasks and assist with QC of Central files.

On your first day we’ll expect you to have:

• Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.

• Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.

• Strong interpersonal, written, and verbal communication skills within a matrixed team.

• Experience working in a self-driven capacity, with a sense of urgency and limited oversight.

• A client-focused approach to work and flexible attitude with respect to assignments/new learning.

• The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).

• An honest and ethical work approach to promote the development of life changing treatments for patients.

• Willingness to work in a matrix environment and to value the importance of teamwork 

• Sound proactive and problem solving skills 

• Sense of urgency to meet study/ country deliverables

• Effective time management in order to meet daily metrics, team objectives, and department goals 

• Romanian and English proficiency (written and oral) French would be a big plus