Senior Clinical Research Associate

Senior Clinical Research Associate for Johnson & Johnson MedTech, hybrid in Diegem, Belgium, 40 hours per week, contract until 31 December 2027. Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson; if selected you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

The role focuses on managing clinical study activities from initiation to close-out for multiple sites conducting company-initiated studies for the MedTech group. You will oversee site performance, foster productive relationships, and serve as the crucial liaison between the clinical study team and study site personnel to ensure the highest standards of data quality and patient safety. This role focuses heavily on Clinical Study Site Management (95%) along with key Administrative Activities (5%).

Responsibilities include: ensuring all work activities embody the Johnson & Johnson Credo Values; verifying safety and well-being of study subjects; supporting operational execution of clinical trials and ensuring collection of high-quality, substantiated data; executing clinical trial activities following SOPs, good clinical practices and regulatory requirements; being accountable for study site performance and providing high-quality data according to overall project timeline; assisting Clinical Operations and study site staff to resolve issues and implement corrective/preventive actions; verifying Investigator Site Files; supporting patient recruitment and retention; performing site visits and ensuring compliance with protocol and regulations; assisting with internal communication of clinical data and events; supporting organization of investigator and training meetings; functioning as a reliable resource of up-to-date study site status knowledge; understanding business value of clinical projects; supporting implementation of new clinical systems/processes; interfacing with investigators, IRBs/ECs, contractors/vendors, and company personnel; and complying with all applicable laws, regulations, and Policies of the Health Care Compliance Program and Code of Conduct.

To be successful, you will have a strong foundation in on-site clinical research monitoring, strict adherence to GCP, and a solid understanding of medical device regulations.

Required: a Bachelor Degree (preferably BSc in Life Science, Physical Science, Nursing or Biological Science); at least 4 years of relevant on-site monitoring experience; previous clinical research experience; previous medical device monitoring or equivalent experience; understanding and application of regulations and standards in clinical research and medical devices/combination products; must have good proficiency in English and Dutch (converse and read medical notes); experience with computer systems (Microsoft Office – Excel, Word, PowerPoint); demonstrated competencies in Leadership, Written and verbal communications, Presentation and influencing, and Strong organizational skills; ability to travel up to 80% of time.

Preferred: French proficiency; relevant industry certifications (CCRA, RAC, CDE); clinical/medical background. This role offers a very competitive hourly rate. The contract will run until 31 December 2027.