Cornerstone International Clinical is seeking a Senior Clinical Research Associate to support the management and monitoring of clinical trials across our research portfolio. You will work closely with investigators, sponsors and internal teams to ensure trials are conducted in accordance with the protocol, applicable regulations and ICH GCP guidelines.
Responsibilities
- Monitor clinical study sites to ensure protocol compliance and data integrity
- Review and verify source documentation and case report forms
- Liaise with site personnel, investigators and project managers throughout the study lifecycle
- Identify, document and follow up on protocol deviations and data queries
- Prepare and submit monitoring visit reports within agreed timelines
- Support site initiation, interim and close-out activities
- Contribute to training and mentoring of junior CRA staff
Requirements
- Degree in life sciences, nursing, pharmacy or a related field
- Minimum three years of clinical monitoring experience in a CRO or pharmaceutical environment
- Solid working knowledge of ICH GCP, EU Clinical Trials Regulation and relevant national legislation
- Excellent organisational skills and attention to detail
- Strong written and verbal communication in English; German an advantage
- Willingness to travel to study sites across Europe as required
#J-18808-Ljbffr
Kontaktdaten:
Cornerstone International Recruiting-Team
