Clinical Trial Associate
Noema Pharma
- Bâle
- CDI
- Temps-plein
- Assists in the provision of study and/or program execution to plan in accordance with CFR, EMA, and ICH GCP regulations.
- Responsible and accountable for supporting assigned clinical study(ies) and assisting in the coordination/execution of assigned operational aspects.
- To assist the Clinical Operations team in completion of all required tasks to meet departmental and project goals.
- To support the Clinical Operations team with ongoing conduct of studies.
- To be familiar with ICH GCP, appropriate regulations, relevant SOP’s and internal tracking systems.
- To assist project teams with generating or maintaining study specific documentation and guidelines as appropriate.
- To set up, organize and maintain with quality all clinical study documentation (e.g. Trial Master File), provide oversight and quality during maintenance through to final reconciliation and archival.
- To assist in co-ordinating and tracking of vendor deliverables and progress, creating or maintaining tracking tools and systems
- To triage incoming correspondence, internal documentation, CRFs, etc., as appropriate, to responsible clinical operations team members.
- To assist in tracking of vendor payments, if applicable.
- To assist in the contact clinical sites for specific requests (e.g., enrollment updates, meeting arrangements, etc.).
- To attend project team meetings and generate meeting minutes.
- To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
- To assist in the production of slides, etc., as needed for project, departmental, vendor and/or company presentations.
- BS/BA degree required in science/health-related field preferred, but not required.
- At least 2 years of clinical research experience in clinical trials in biotech or pharma industry.
- General understanding of the drug development process to assist in the management of deliverables, as assigned.
- Ability to manage and organize multiple priorities, while maintaining attention to detail.
- Self-motivation and able to work independently in a fast-paced, small company environment.
- Pro-active and problem-solving attitude: willing to work hands-on in a very small team with limited internal resources.
- Strong work ethics.
- Personal resilience, perseverance, energy and drive.
- Working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
- Open, effective, and proactive written and oral communication skills.
- Fluent in spoken and written English, additional languages are an asset.