Clinical Trails Assistant
vor 2 Monaten
IQVIA Clinical FSP business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our clients. We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study.
Leadership recognizes the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows. Our managers understand the sponsors priorities and the individual aspects of each model. Focus is given to career development from day one, including new hire orientation and onboarding, day to day problem solving and training and development.
This full-time Clinical Trial Assistant position will be office based in Lucerne with the possibility of working from home 1 day per week. The CTA will support both countries Switzerland and Austria.
**While projects vary, your typical responsibilities might include**:
Trial and Site Administration:
- Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request
Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- Execute eTMF Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents
Regulatory & Site Start-Up responsibilities:
Collaborate with other country roles to
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
- Publish study results for GCTO and RA where required per local legislation
**You should have**:
- Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience
- Fluent in German and business proficient in English (verbal and written) and excellent communication skills, Italian and French are a plus
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines; ICH-GCP Knowledge appropriate to role
- Hands on knowledge of Good Documentation Practices
Whatever your career goals, we are here to ensure you get there
**We invite you to join IQVIA.
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