Instituto Pedro Nunes (IPN) is looking for a professional to join its team as a Senior Clinical Research Assistant (CRA), contributing to the planning, coordination, and monitoring of clinical studies in the field of medical devices, with a particular focus on active medical devices, AI-enabled medical devices, and robotic technologies.
Operational functions:
- Act as a Senior CRA responsible for the end-to-end oversight of clinical investigations and usability studies for medical devices, with a focus on innovative and early-stage development projects;
- Lead the planning and conduct of clinical studies for medical devices in compliance with applicable regulations and standards;
- Support startups in the preparation of documentation for clinical studies, including Clinical Investigation Protocol (CIP), Investigator Brochure (IB), Trial Master File/Investigator Study File (TMF/ISF), Informed Consent Forms (ICFs), and additional documentation required by regulatory authorities;
- Serve as the primary point of contact for investigators, clinical sites, ethics committees and, where applicable, competent authorities;
- Oversee the implementation of clinical investigations, usability testing, and other clinical validation activities;
- Ensure compliance with the CIP, ISO 14155, and Regulation (EU) 2017/745 on Medical Devices (MDR) through monitoring activities and the implementation of Corrective and Preventive Actions (CAPA), ensuring data quality and data integrity;
- Manage study documentation and data collection tools;
- Contribute to study reporting and communication with stakeholders;
- Support the preparation of applications for European projects (e.g., Horizon Europe), contributing to the definition of clinical and validation work packages, study design, methodologies, and resource planning;
- Where applicable, mentor junior clinical staff and support process improvement initiatives.
Profile:
- Minimum Qualification: Bachelor's degree in Health Sciences, Biomedical Engineering, Nursing, or related fields;
- Professional Experience: Minimum of 4 to 6 years of experience in clinical research, preferably in CRA or Senior CRA roles.
Offer:
- Integration into a solid organization with national and international prestige;
- Participation in innovative national and European projects of high relevance;
- Collaboration with hospitals, startups, and research teams;
- Continuous training and professional development opportunities;
- Salary conditions aligned with the candidate’s profile and professional experience.
Technical Competencies:
- Demonstrate strong knowledge of ISO 14155, MDR, clinical evaluation, and the regulatory framework applicable to medical devices;
- Demonstrate the ability to work independently, manage multiple studies, and effectively prioritize workloads;
- Experience in clinical investigations and/or observational studies involving medical devices;
- Experience in international or multicentre studies;
- Demonstrate familiarity with MedTech innovation ecosystems, startup environments, and European Union-funded projects;
- Knowledge of European market access and the medical device development lifecycle;
- Fluency in Portuguese and English, both written and spoken.
Transversal competencies:
- Demonstrate strong attention to detail and accuracy in data management;
- Demonstrate analytical skills and critical thinking;
- Proactive, autonomous, and results-oriented mindset;
- High sense of responsibility and autonomy;
- Communicate clearly and effectively, both verbally and in writing;
- Ability to work effectively within a team, collaborating with professionals from different backgrounds and areas of expertise.
Applications should be submitted by sending a CV and cover letter to las@ipn.pt, indicating reference “Application Senior Clinical Research Assistant (CRA) - Medical Devices, ref: IPN/LAS/2026/CON2.", by 30 July 2026.
Instituto Pedro Nunes informs that the personal data provided by candidates within the scope of this recruitment procedure will be used exclusively for the assessment of applications. The data will be processed in accordance with our Data Protection and Privacy PolicyInstituto Pedro Nunes is responsible for the processing of personal data, namely that sent by candidates in the context of this recruitment procedure. The data of non-selected candidates will be deleted after the end of the process, unless they consent to retention for future opportunities or legal obligation. Candidates have the right to access, rectify, erase, limit, oppose the processing and request the portability of their data, and may exercise these rights via the following e-mail address: rgpd-ipn@ipn.pt. For more information, please consult our Data Protection and Privacy Policy
IPN is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on the basis of sex, age, disability, ethnicity, religion, or sexual orientation.
