Clinical Assistant

Posted 2 Days Ago
Be an Early Applicant
Bucharest, București, ROU
In-Office
Entry level
Pharmaceutical
The Role
Supports clinical operations teams throughout trial startup, maintenance, and closeout. Responsibilities include site activation, vendor system access, training coordination, material shipments, Trial Master File management, document and training follow-up, CTMS and study tracker updates, issue escalation, equipment returns, and database lock coordination. The role requires compliance with ICH-GCP, local regulations, and company procedures while maintaining accurate, inspection-ready trial documentation.
Summary Generated by Built In

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.

Skills Required

  • Strong computer skills
  • Proficiency in Clinical Trial Management Systems and Electronic Document Management Systems
  • Advanced Microsoft Office skills, including Excel and Word
  • Fluent English, oral and written
  • Local language proficiency
  • Exceptional organizational abilities and ability to manage multiple priorities
  • Strong written and oral communication skills
  • Problem-solving ability and creative thinking under pressure
  • 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
  • Knowledge of ICH-GCP Guidelines, local regulations, and company procedures

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

Parexel Insights

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The Company
HQ: Raleigh, NC
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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