CRA - Medical Device

2 weeks ago

Stockholm, Stockholm, Sweden Medhouse Full time

We are assisting SmartCella in finding a motivated Clinical Research Associate with  experience in medical device trials to join their growing Target Delivery team

SmartCella is a world-leading biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned science and research from Karolinska Institutet in Sweden. SmartCella combines novel delivery platforms, such as the Extroducer (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell-mediated therapies. The company operates in two business segments: Targeted Deliveries and Regenerative Medicines.


About The Position
As Clinical Research Associate (CRA) you will play an integral role in the planning, coordination, and execution of medical device clinical trials, including studies with combination product components (drug + device). The role requires collaboration with both clinical study sites, partners and CROs, ensuring compliance with ISO 14155, ICH-GCP, local regulations, and company SOPs.

Medical device trial experience is required, while additional exposure to drug and therapeutic trials is an advantage. As we operate globally, good English skills, both spoken and written, are a requirement.


Key Responsibilities


• Support study start-up, feasibility, submissions, and essential documentation.


• Conduct and/or support site monitoring (remote and on-site)


• Act as point of contact for investigators and site staff.


• Coordinate and oversee CRO activities and deliverables.


• Maintain the Trial Master File (TMF) and study documentation.


• Track enrollment, product/device accountability, and safety reporting.


• Contribute to study reports and regulatory filings.


Clinical Focus Areas:


• Medical Devices: Core specialty with ISO 14155 expertise.


• Collaboration: Working across both sites and CROs.


Qualifications


• Minimum Bachelor's degree in life sciences, nursing, pharmacy, biomedical engineering, or related field.


• Minimum 2–4 years' experience as a CRA in medical device trials.


• Knowledge of ISO 14155 essential.


• Experience with both study site and CRO collaboration desirable.


• Strong organizational and communication skills.


• Proficiency with MS Office and clinical trial systems (CTMS, eTMF).


• Willingness to travel.


Other Information

This is a full-time position at SmartCella

Office location: Stockholm 

Interested? Submit your application today We will review applications on an ongoing basis and hope to fill the position as soon as possible. You apply for our positions by registering your CV and answering the selection questions for each respective role. With us, you apply without a personal cover letter and instead have the opportunity to explain your interest in the position through the questions provided in the application form.

Do you have any questions about the position?
Please feel free to contact Anna Maria Lindqvist, anna- or Louise Jonsson,

We warmly welcome your application today

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