Junior Clinical Research Associate

About the role

We are seeking a Junior Clinical Research Associate to support the design, implementation and monitoring of clinical investigations and post‑market studies for our innovative women’s health medical devices. The role will work closely with investigative sites, regulatory and quality teams to ensure compliance with all applicable regulations.

Key responsibilities

• Prepare and submit documents to IRBs/Ethical Committees, including protocols, case report forms, investigator brochures and informed consent forms.
• Assist in the preparation of interim, annual and FDA study reports.
• Communicate with investigative sites and consultants, conduct site qualification, initiation, monitoring and close‑out visits.
• Perform source data verification and ensure data quality on CRFs.
• Collaborate with biostatisticians to discuss study results and contribute to clinical trial reports.
• Archive study documentation and prepare final study reports.
• Provide clinical support for Quality Affairs (clinical complaints, FMEA) and Regulatory Affairs (clinical evaluation reports, technical files).
• Stay current with ethical, scientific and regulatory guidelines (ISO, MEDDEV, MDR, etc.).

Required profile

• Bachelor’s degree in health, life sciences or a related field.
• Strong understanding of clinical trial processes and regulatory requirements.
• Excellent written and verbal communication skills.
• Detail‑oriented with ability to manage multiple tasks.

Required skills

• IRB/Ethical Committee submission
• FDA reporting
• Case Report Form (CRF) management
• Failure Mode and Effect Analysis (FMEA)
• Clinical Evaluation Report preparation
• Knowledge of ISO, MEDDEV and MDR guidelines