Clinical Research Associate Medical Devices
Starting up from your home office with e-mails before you visit a university hospital for conducting a site initiation, your day is a variety of activities and places.
What makes your work as a Clinical Research Associate diverse and challenging is that you support clinical studies with a variety of devices, indications and study designs. Where one project is in the phase of answering questions from the Ethics Committee, on another project you are fully involved in the interim monitoring of a multicenter study. You will be dedicated to our client projects and sites throughout Germany and in other countries if the need arises. Within the CRO, you are the go-to person when it comes to study support in Germany. In addition to that, you actively participate in the study teams and bring in your experience with monitoring, document development and study execution.
Does this sound like your new job? Then Qserve CRO, a growing organization with a lot of freedom and also a high level of exposure and steep learning curve, is looking for you:
An early-mid-career CRA with an affinity for medical devices.
This is what you will be doing at Qserve:
As a Clinical Research Associate at our CRO you are responsible for monitoring, site management, document review and development and regulatory submissions for clinical investigations of medical devices and in-vitro diagnostic devices. In close collaboration with the Clinical Project Manager (CPM), you develop study documents, secure ethics approval and competent authority approval, and manage the research sites assigned to you. You conduct interim monitoring visits as well as site qualification, initiation and close-out visits. You provide GCP training sessions to site personnel. Most studies are in Germany but you sometimes step in when help is needed with a study in The Netherlands, Belgium, UK, Austria or Switzerland. Besides the everyday operations, you participate in strategic clinical projects including the writing of study protocols and other study plans and reports. You advise the CPM on submission strategies and recruitment strategies in Germany.
And this is what you will bring:
- Technical or scientific degree (MSc or PhD) in a health-related field, biology, medical, biomedical engineering or similar.
- 1-3 years’ experience as Clinical Research Associate (CRA).
- Experience with medical devices is preferred.
- Experience with study start-up, ethics committee (EC) and competent authority (CA) submission, site qualification, initiation, monitoring and close-out and writing and reviewing study documentation is required.
- Ability to work in small teams with high individual exposure and responsibility.
- Fluent in German and English.
- Able to travel frequently to our office in The Netherlands, often to sites across Germany and occasionally to sites elsewhere in Europe.
- Working permit and driver’s license for Germany.
- Freelance opportunities are open for discussion.
Qserve is constantly looking for professionals at different career levels with experience in regulatory affairs, quality assurance, clinical affairs, clinical trials or auditing in the area of medical devices and in vitro diagnostic devices. We are a worldwide operating and fast-growing regulatory consulting and CRO in the medical device sector with our largest base in Europe, and local teams in China and the USA.
Is this your DNA?
Do you find pride in supporting customers in line with professional and ethical values? Do you have a practical approach and like being creative in finding solutions? Please take a look at our career opportunities at Qserve. We would like to get in contact with you!
Why choose Qserve?
Qserve has an international and dynamic work environment in which you can learn, develop and operate in the innovative, fast-moving medical device sector. We offer flexibility and diversity in terms of clients, devices, technology, roles (author, reviewer, expert, trainer, auditor, etc.) and projects. Work together, learn from and be part of a strong international team with technical, regulatory, quality and clinical competences (altogether over 500 years of experience). And last but not least we offer a balanced set of core benefits that we believe are important to all employees.