Senior Clinical Research Associate - Sponsor dedicated - Belgium - Home based (m/w/d)
Core
Senior Clinical Research Associate conducting on-site monitoring for dedicated sponsor programs in Belgium.
Role type
Senior Clinical Research Associate (Sponsor Dedicated)
Builds
Clinical research programs for pharmaceutical and biotechnology sponsors
Domain
Life Sciences / Clinical Research
Required skills
GCP/ICH guidelines, site monitoring, patient safety, data integrity, protocol compliance, risk management, cross-functional collaboration
Preferred skills
Mentorship, continuous improvement, therapeutic area expertise
Technologies
None stated
Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits; Ensure investigational sites maintain high standards of patient safety, data integrity, and protocol compliance; Build and maintain effective relationships with investigators and site personnel; Monitor study progress, including regulatory documentation, patient recruitment, and data query resolution; Collaborate with sites to implement patient recruitment and retention strategies; Maintain accurate study documentation including ISF and TMF; Identify and escalate study risks and quality concerns; Partner with cross-functional teams to support study execution; Mentor junior clinical team members; Contribute to study start-up, maintenance, close-out, and site financial activities.
Seniority
Senior, hands-on IC