Job Description
The Clinical Trial Coordinator provides administrative and technical support to clinical trial project teams, ensuring accurate study documentation, audit readiness, regulatory compliance, and timely site activation. The role involves coordinating clinical trial activities, maintaining electronic Trial Master Files (eTMF), supporting site feasibility assessments, tracking study progress, and collaborating with investigators, site personnel, sponsors, and internal teams to ensure efficient clinical trial execution.
Key Responsibilities
- Review and maintain Trial Master Files (TMF/eTMF), Investigator Site Files (ISF), and regulatory documentation.
- Support site activation, start-up activities, feasibility assessments, and site selection.
- Track study milestones, project metrics, vendor activities, and regulatory documents.
- Ensure documentation accuracy, audit readiness, and compliance with applicable SOPs and regulatory guidelines.
- Coordinate document distribution, regulatory submissions, meeting schedules, and meeting minutes.
- Communicate project risks, site issues, and documentation findings to project leads and management.
- Support investigator communications, site contact follow-ups, and study-specific training.
- Collaborate with global and local teams to meet project timelines and improve operational processes.
Qualifications
- Bachelor's degree preferred.
- High school/secondary school diploma or equivalent with relevant formal academic or vocational qualifications.
- Basic knowledge of medical terminology, clinical research, and local healthcare systems.
- Working knowledge of Good Clinical Practice (GCP), applicable regulations, and Standard Operating Procedures (SOPs).
Experience
Approximately 2 years of relevant experience, or an equivalent combination of education, training, and directly related experience.
Experience in clinical trial coordination, clinical research administration, regulatory documentation, or project support is beneficial.
Familiarity with clinical trial databases, documentation systems, and site activation processes is advantageous.
Skills Required
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Ability to manage multiple tasks, deadlines, and changing priorities.
- Knowledge of GCP, SOPs, and applicable country-specific regulations.
- Strong analytical, documentation, and problem-solving skills.
- Teamwork, interpersonal communication, and relationship-building abilities.
- Risk identification, escalation, and time-management skills.
- Ability to learn and use clinical trial management systems (CTMS), eTMF, and other project databases.
- Fluency in French and excellent English proficiency, with local-language proficiency as required.
Additional Information
| Company | Thermo Fisher Scientific |
|---|---|
| Location | Saint Aubin / Calvados / France |
| Job Type | Full Time |
| Experience Level | Mid-level / Experienced professional |
| Company Website | https://jobs.thermofisher.com/global/en ↗ |
| Source | Official Career Page ↗ |
| Experience Level | Mid-level / Experienced professional Employment Type: Not specified Department: Clinical Operations / Clinical Trial Support Work Environment: Office, laboratory, clinical site, or home office Travel Requirements: Occasional travel to clinical sites may be required Work Arrangement: Not specified Primary Focus: Clinical trial coordination, site activation, documentation, and regulatory compliance Systems and Tools: CTMS, eTMF, clinical trial databases, Microsoft Office Regulatory Knowledge: Good Clinical Practice (GCP), SOPs, and applicable clinical research regulations Language Requirements: French, English, and local languages as applicable Training: Completion of the organization's clinical training program Application Deadline: Not specified |
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