Senior Clinical Research Associate

Cornerstone International; München; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

Cornerstone International Clinical is seeking a Senior Clinical Research Associate to support 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 include monitoring sites for protocol adherence, reviewing source data, coordinating with site staff and project managers, and

Qualifications

• 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 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.

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.

Skills

Communication skills

Organisational skills

Attention to detail

English language proficiency

Education

Degree in Life Sciences/Healthcare

Job description

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