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Clinical Research Associate (f/m/d)
Ver: 161
Día de actualización: 17-04-2024
Ubicación: Chur Graubünden GR
Categoría: R & D IT - Software
Industria: Medical Equipment Manufacturing
Posición: Associate
Tipo de empleo: Full-time
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Contenido de trabajo
Company / Business Unit:Hamilton Medical AGmore informationResponsibilities:- Define study specific source data verification strategy with Clinical Trial Leader
- Support study specific Ethical Committee and Competent Authority submissions
- Perform start up, site activation and site monitoring activities/visits according to applicable regulations, SOPs and work instructions
- Communicate visit findings with site personnel and complete a written letter for distribution to the Principal, Investigator, and appropriate site personnel for follow-up
- Prepare site visit reports and correspondence for all visits conducted in accordance with the study monitoring plan
- Identify site needs and provide solutions to facilitate the clinical trial process
- Document coordination - creates and manages the clinical study files and oversees the organization and distribution of clinical study documents
- Assists with periodic audits of clinical study files for completeness and accuracy
- Provide project coordination and support to Clinical Trial Leader
- Assists/coordinates in the organization and distribution of clinical study documentation
- May assist in tracking study activity, such as start-up progress by ensuring receipt of proper study documentation, agreements, and site approvals
- May work with clinical study teams to create and distribute newsletters and communications to sites
- Create, run, and monitor metrics and maintenance site specific reports on an ongoing basis
- Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or medical device development
- At least 2 years’ relevant experience
- Fluency in English and either Spanish, Portuguese and or Italian languages verbally and in writing
- Experience with word processing, spreadsheets, and database applications (e.g., MS Word and Excel)
- Willingness to travel and overnight stays in Europe
- Independent and proactive mindset
- Good interpersonal skills
- Ability to work in a fast-paced environment
- High attention to detail and accuracy and excellent problem-solving skills
- The ability to work in a team environment and adhere to the highest personal and ethical standards with a commitment to GCP clinical research
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Plazo: 01-06-2024
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