Clinical Assistant

About the Role

Are you organized, detail-oriented, and passionate about supporting clinical excellence? Parexel is seeking a Clinical Operations Assistant (COA) to join our dynamic Clinical Operations team in Bucharest, Romania.

In this pivotal role, will complete administrative tasks on behalf of assigned Project Clinical Team member which might include site management tasks during the different phases of a clinical trial as startup, maintenance and termination, contributing to the efficiency, accuracy, and quality of the trials.

Key Responsibilities

• Site Activation – Assisting site staff through vendor system access, coordinate training, and manage material shipments
• Trial Master File (TMF) Management – Upload documents on time, update Expected Document Lists, and resolve Quality Issues proactively
• Site Maintenance – Follow up on pending documents, trainings, and data entry; ensure inspection readiness
• Progress Tracking – Update CTMS and study trackers with site information; identify and escalate potential issues
• Project Closeout – Coordinate equipment returns and database lock activities with clinical teams
• Compliance – Maintain knowledge of ICH-GCP Guidelines, local regulations, and Parexel procedures.

What We're Looking For

Essential Skills:

• Strong computer skills; Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Document Management Systems (EDMS) would be advantage.
• Advanced MS-Office skills (Excel, Word) – you're comfortable with data and spreadsheets
• Fluent English (oral and written), plus local language proficiency
• Exceptional organizational abilities with the capacity to juggle multiple priorities without dropping the ball
• Strong written and oral communication skills – you can explain complex processes clearly to internal and external stakeholders
• Problem-solving mindset with the ability to think creatively under pressure

Ideal Background:

• Bachelor's degree in Life Sciences or a related field (or equivalent professional experience)
• Experience in office management within an international environment
• Familiarity with clinical trial operations or healthcare administration
• Knowledge of regulatory requirements in clinical research

Why Join Parexel?

At Parexel, you'll work on cutting-edge clinical trials that transform patient lives. You'll be part of a global organization that values precision, integrity, and innovation. We invest in our people, offering opportunities for professional growth, continuous learning, and career advancement. If you're someone who takes pride in accuracy, thrives in a fast-paced environment, and wants to make a real impact in clinical research, we want to hear from you.