Clinical Research Associate II - Home Based (m/w/d)

About the role

IQVIA Biotech, which works with smaller biotech and emerging biopharma clients, has a position in its EU Clinical Monitoring team, the largest team in IQVIA Biotech. The role is home-based and requires being based in Belgium. It involves monitoring Phase I-IV clinical trials in line with Good Clinical Practice.

Key responsibilities

• Take part in preparing and running Phase I-IV clinical trials and monitor them according to GCP and IQVIA Biotech procedures.
• Evaluate sites, initiate studies and carry out interim close-out visits, working with the Clinical Trial Manager and/or Lead CRA.
• Help recruit investigators, coordinate site preparation, run study initiation and close-out, and train sites on eCRF and EDC completion.
• Ensure compliance with site file audits, perform source documentation validation and document accountability, stability and storage of trial materials.
• Review electronic CRF data and verify sources on site, resolve data queries and prepare monitoring reports and letters.
• Act as primary contact with investigators, attend investigator meetings and study-related meetings, and ensure deliverables meet timelines.
• Mentor junior CRAs and conduct field evaluation visits and training of CRA Is, IIs and other senior CRAs.

Required profile

• Minimum of 1-2 years of onsite monitoring experience.
• Strong written and spoken Dutch and English; French is a plus.
• Able to work independently, prioritise and work in a matrix team environment.

Required skills

• Good knowledge of the clinical research process and medical terminology.
• Knowledge of current GCP/ICH guidelines.
• Excellent communication skills and ability to build professional relationships with healthcare professionals.