Clinical Trials Operations Specialist

1 month ago


Perth, Western Australia Thermo Fisher Scientific Full time

About the Opportunity

We are seeking a highly motivated and detail-oriented Clinical Trials Operations Specialist to join our team. This role will provide administrative and technical support for clinical trials, ensuring timely completion of tasks and maintaining high-quality standards.

The Role

In this role, you will perform department, internal, country, and investigator file reviews as assigned, documenting findings in relevant systems. You will also ensure allocated tasks are completed on time, within budget, and to a high standard, proactively communicating any risks to project leads.

Key Responsibilities

  1. Perform system support (Activate & eTMF) and ensure system databases are up-to-date.
  2. Process documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed.
  3. Support scheduling of client and/or internal meetings.
  4. Maintain vendor trackers and support regulatory submissions.
  5. Work directly with sites to obtain documents related to site selection.
  6. Collaborate with teammates to achieve targeted goals for assigned projects.

Requirements

  • High school diploma or equivalent, with a Bachelor's degree preferred.
  • Previous experience providing administrative and technical support for clinical trials.
  • Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
  • Excellent English language and grammar skills, with proficient local language skills as needed.
  • Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint), and able to learn clinical trial database systems.
  • Effective oral and written communication skills.
  • Crucial judgment and decision-making skills.

What We Offer

We offer competitive remuneration ($60,000 - $80,000 per year), annual incentive plan bonus, healthcare, and a range of employee benefits. Our company culture values integrity, intensity, innovation, and involvement, working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.

Grow Your Career with Us

Thermo Fisher Scientific offers continued career advancement for early careers Clinical Trial Coordinators to progress to Clinical Research Associates. We pride ourselves on promoting from within, with flexible promotion cycles throughout the year.



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