Job title: Senior Clinical Research Associate (CRA) (m/f/d)
Location: Germany (remote options/hybrid set-up)
Salary: Negotiable
Permanent/Full - time
One of my top clients is looking for an experienced Clinical Research Associate to join their growing European team as a 'Senior CRA'. They are looking for a highly organized individual with excellent communication skills and a positive, self-initiating attitude to conduct clinical investigations related to medical devices across Europe.
My client is a key player in the medical devices industry globally, giving you the opportunity to be part of an international team providing high-class medical devices to individuals & organizations across the world to help patients across multiple areas of medical specialties. You would be working in a global-facing role, coordinating with a range of cross-functional teams, and be part of a family of like-minded people across the company's various country groups.
Key responsibilities:
- Looking after entirety of clinical studies, in line with the CIP (clinical investigation plan), company/national/international guidelines
- Supporting application of medical device studies in line with relevant regulations, including obtaining approval from Ethics Committees and reviewing Case Report Forms (CRF)
- Autonomously supervising & training clinical sites in accordance with relevant plans by preparing and conducting various site visits as well as conducting related communication/reports
- Verifying CRF entries against sources and ensures consistency with patients' data; establishing whether clinical trial/study documentation is recorded/reported in accordance with the correct practices, procedures and requirements e.g. ISO 14155
- Collaborating between monitoring & study teams to resolve serious issues and re-instate compliance on sit; ensuring stock levels on site are appropriate & reporting discrepancies to relevant internal parties
- Reviewing & contributing to clinical study-related documents, plans and training resources such as CIP, Investigator Brochure, Progress Report, Training Plan and Audit Plan
- Supporting the Clinical Project Manager to develop study-related documents for individual countries and assisting in reviewing monitoring reports
Key requirements:
- Bachelors or Masters degree in Health/Life Sciences or background as a Nurse
- At least 4 years' experience working in a leadership CRA role in a hospital and/or medical device environment
- Experience in examining monitoring reports and preparing Ethic Committee submissions
- Thorough understanding of medical device regulatory requirements, e.g., ISO 14155: 2020, EU-MDR, device accountability and adverse events reporting
- Successful track record working in a global-facing role and working independently; excellent problem solving & inter-personal skills, ability to coordinate a team successfully
- Fluent German and English (additional language is advantageous)
- Willingness and ability to travel across Europe bi-monthly and full drivers' license