Hamilton Medical AG is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan - our solutions cover a multitude of patient groups, applications and environments.
Responsibilities:
Define study specific source data verification strategy with clinical trial lead
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 Lead
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 teams to create and distribute newsletters and communications to sites.
Create, run, and monitor metrics and maintenance site specific reports on an ongoing basis
You should bring along the following qualifications:
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' experience
Capable of clearly and effectively communicating in English and Spanish verbally and in writing
Independent and proactive mindset
Good interpersonal skills
Ability to work in a fast-paced environment
High attention to detail and accuracy
The ability to work in a team environment and adhere to the highest personal and ethical standards with a commitment to GCP clinical research
Excellent problem-solving skills
Experience with word processing, spreadsheets, and database applications (e.g., MS Word and Excel)
Travel expectations is up to 30% in Europe
Are you interested? Then please apply online by clicking on the "Apply" button. If you have any questions, please do not hesitate to contact with the following details:
Reference: JR-2918/Contact: Sina Bandli
Applications by post or e-mail can unfortunately not be considered.