Thermo Fisher Scientific is a pioneer in life sciences, enabling advancements that make the world healthier, cleaner, and safer. Through its PPD® clinical research portfolio, the company offers laboratory, digital, and decentralized clinical trial services across more than 100 countries. This ensures the development of life-saving drugs and therapies. Working at Thermo Fisher means being part of a dynamic organization committed to integrity, innovation, and continuous learning.
Responsibilities in the Job
As a Clinical Trial Coordinator I, you will play a key role in supporting the delivery of clinical trials with speed and accuracy. Your duties will include both administrative and technical tasks essential for successful site activations and study operations. Here’s a breakdown of the responsibilities:
- Audit Support:
- Ensure files are reviewed in accordance with SOPs and department guidelines.
- Maintain audit readiness through regular system updates.
- Site Activation and Feasibility:
- Use local site knowledge and sponsor directives to support rapid site activations.
- Provide inputs for the site tiering process and strategic feasibility planning.
- Regulatory Compliance:
- Assist with tracking and reviewing regulatory documents.
- Support the start-up team with submissions to regulatory bodies.
- Administrative Tasks:
- Manage document submissions to (e)TMF systems and review findings.
- Maintain internal trackers for vendors and study documents.
- Schedule meetings for clients and internal teams as required.
Qualifications Required
To be successful in this role, the following qualifications are necessary:
- Education:
- A Bachelor’s degree is preferred, though relevant academic or vocational qualifications will be considered.
- Experience:
- 6 months to 1 year of relevant experience in clinical research or a similar environment is required.
Skills and Abilities
The ideal candidate should demonstrate the following skills:
- Teamwork & Independence: Ability to work effectively both independently and as part of a team.
- Time Management: Flexibility to manage changing priorities and project timelines.
- Regulatory Knowledge: Familiarity with ICH Good Clinical Practices and relevant country regulations.
- Communication Skills: Strong oral and written communication in English, with local language proficiency as needed.
- Digital Proficiency: Experience using MS Office tools (Word, Excel, PowerPoint) and the ability to learn clinical trial databases quickly.
- Critical Thinking: Solid judgment and decision-making abilities to handle project challenges.
