Clinical Research Associate
2 days ago
We are assisting SmartCella in finding a motivated CRA with experience in medical device trials to join their growing Target Delivery team
An exciting opportunity to contribute to innovative projects and make a real impact in patient care
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
-
Senior Clinical Research Associate, Contractor
2 weeks ago
Stockholm, Stockholm, Sweden Biorasi Full time 650,000 - 850,000 per yearWe are Growing Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization.Biorasi is looking for top performers who are as passionate about clinical research...
-
Stockholm, Stockholm, Sweden Region Stockholm Full time 960,000 per yearTema Cancer, Forskning och utbildning Vill du spela en nyckelroll i utvecklingen av framtidens cancerbehandlingar? Vi söker nu en Senior Clinical Research Associate som vill arbeta i ett högkompetent forskningsteam och driva akademiska kliniska prövningar på Karolinska Universitetssjukhuset. Välkommen med din ansökanDu erbjudsett arbete med...
-
Freelance Clinical Research Nurse
2 days ago
Stockholm, Stockholm, Sweden Actalent Full time 500,000 - 800,000 per yearA leading CROare looking for aFreelance Clinical Research NurseinStockholm, Sweden.This is an exciting opportunity with candidates to start as soon as possible and great opportunity to gain industry experience.The Clinical Research Nurse must have minimum 1 year clinical research experience as the CRO need an individual who can work independently as well as...
-
Clinical Specialist
2 days ago
Stockholm, Stockholm, Sweden Masimo Full time 650,000 - 1,200,000 per yearJob DescriptionThe position:In this high-profile role as Clinical Specialist (CS) you will have the unique fortune to shape, foster and develop strategic relationships with a variety of clinical leaders in targeted hospitals and other healthcare markets. Responsible for clinical targets, plus responsible to support the distributor and OEM with Clinical...
-
Associate Director of Applied Biostatistics
2 days ago
Stockholm, Stockholm, Sweden Red Door Analytics Full time 100,000 - 150,000 per yearKey detailsCompany- Red Door Analytics ABLocation- Stockholm, Sweden (this is an in-office position only)Salary- Competitive salary, company pension, and other benefits.Job type– Full-time, although we will consider part time (at least 60%).Start date– 12th January 2026, negotiable.About Red Door AnalyticsRed Door Analytics (RDA) is an independent...
-
Clinical Specialist
2 days ago
Stockholm, Stockholm, Sweden Masimo Full time 900,000 - 1,200,000 per yearDescriptionThe position: In this high-profile role as Clinical Specialist (CS) you will have the unique fortune to shape, foster and develop strategic relationships with a variety of clinical leaders in targeted hospitals and other healthcare markets. Responsible for clinical targets, plus responsible to support the distributor and OEM with Clinical...
-
Clinical Trial Psych Rater
2 days ago
Stockholm, Stockholm, Sweden IQVIA Full time 400,000 - 600,000 per yearClinical Specialist Consultant – Norwegian SpeakingLocation: Remote/VirtualHours: Estimated 10–16 hours per monthRole: Clinical SpecialistAbout IQVIAIQVIA is a global leader in advanced analytics, technology solutions, and clinical research services, dedicated to driving healthcare forward. We partner with the world's leading pharmaceutical,...
-
Stockholm, Stockholm, Sweden ProPharma Full time 900,000 - 1,200,000 per yearFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the...
-
Founders Associate
2 days ago
Stockholm, Stockholm, Sweden Corner Full time 60,000 - 120,000 per yearFounder's Associate|Be part of redefining how athletes and fans connectAt Corner, athletes take control of their audience and unlock new ways to grow, earn, and connect. We're building the platform where athletes own their communities and monetize directly through subscriptions, sponsorships, and donations.We are looking for a Founder's Associate, a driven...
-
Research assistant
2 weeks ago
Stockholm, Stockholm, Sweden SciLifeLab Full time 100,000 - 120,000 per yearThe Department of Biochemistry and Biophysics.SciLifeLab (SciLifeLab) is a national center for molecular biosciences with focus on health and environmental research. The center combines frontline technical expertise with advanced knowledge of translational medicine and molecular bioscience. SciLifeLab is a national resource hosted by Karolinska Institutet,...
