Clinical Research Associate/Clinical Trial Assistant

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.

To our Targeted Deliveries segment, the business unit SmartWise Sweden AB, are we now seeking a Clinical Reasearch Associate/Clinical Trial Assistant to join our growing team.

About The Position

As Clinical Research Associate (CRA) / Clinical Trial Assistant (CTA) 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.

• Combination Products: Involvement in drug–device interface studies.

• Therapeutics: Familiarity with ICH-GCP drug trials advantageous.

• 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 or CTA, preferably in medical device trials.

• Knowledge of ISO 14155 essential; familiarity with ICH-GCP a plus.

• 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 (for CRA role).

Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.

The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 82 employees from more than 20 nationalities.