Regulatory Affairs Assistant & Clinical Trial Coordinator II at Thermo Fisher Scientific
Location: Work From Home
Organization: Thermo Fisher Scientific
Positions:
- Regulatory Affairs Assistant
- Clinical Trial Coordinator II
Experience: 2-5 years
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc in Life Sciences
Salary: Not disclosed
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in clinical research services, dedicated to advancing novel treatments and supporting drug development through unparalleled clinical and scientific expertise.
Responsibilities
Regulatory Affairs Assistant:
- Administrative Support: Schedule meetings, organize travel, and manage expenses.
- Document Management: Archive, retrieve, and ensure up-to-date regulatory documentation.
- Process Support: Administer and update Work Process Documents (WPDs) and Standard Operating Procedures (SOPs).
- Tool Maintenance: Support the upkeep of departmental websites and tools.
- Regulatory Compliance: Maintain records and filings to ensure adherence to regulations and audit readiness.
Clinical Trial Coordinator II:
- Project Support: Assist with administrative and technical tasks, ensuring timely document processing.
- Site Management: Develop and review site activation plans and ensure compliance with SOPs and regulatory guidelines.
- Collaboration: Support site start-up activities and regulatory submissions.
Qualifications
Regulatory Affairs Assistant:
- High school diploma or equivalent.
- 2+ years of relevant experience, preferably in CRO or pharmaceutical sectors.
Clinical Trial Coordinator II:
- Bachelor’s degree in Life Sciences.
- 2-5 years of experience as a Clinical Trial Coordinator (CTC) or Clinical Research Coordinator (CRC).
- Knowledge of regulatory compliance, ICH GCP principles, and eTMF.
Skills
- Organizational Skills: Manage multiple projects and meet deadlines.
- Attention to Detail: Precision in data analysis and documentation.
- Communication Skills: Strong written and verbal skills in English and regional languages.
- Technical Proficiency: Familiarity with clinical trial databases and Microsoft Office.
- Team Collaboration: Excellent interpersonal skills and ability to work independently or in a team.
- Problem-Solving (Clinical Trial Coordinator II): Identify and address issues on site.
- Instructional Proficiency (Clinical Trial Coordinator II): Onboard new hires and orient them to processes.
How to Apply
Interested candidates should visit our careers page to apply. Submit your resume and a cover letter detailing your experience and fit for the role.