CRA Switzerland

StudySmarter; Biel; Hybrid; CHF 56.000 - 69.000; Vollzeit

Benefits dieser Stelle

Career development

Total rewards program

Zusammenfassung

StudySmarter is seeking a Clinical Monitor to support single-sponsor trials in Switzerland. You will perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) to ensure regulatory and protocol compliance, data integrity, and patient safety.

In this role you will manage IP inventory, train site staff, support audit readiness, and drive timelines. Fluent German and French are required; ability to travel up to 75% is expected, with cross-functional

Qualifikationen

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
• Previous monitoring experience in Switzerland.
• Strong computer skills and ability to adopt new technologies.
• Excellent communication, presentation and interpersonal skills.
• Fluency in German and French; Italian is an asset.
• Ability to travel up to 75%.
• Collaborative, cross-functional teamwork.
• ICH-GCP knowledge Regulatory knowledge Electronic data capture awareness.

Aufgaben

• Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) with regulatory and protocol compliance.
• Assess site processes, conduct source document review, and verify CRF data accuracy and completeness.
• Manage IP inventory, labeling, and storage considerations; ensure IP dispensing per protocol.
• Lead query resolution and recommend site actions to maintain data quality within CMP/SMP guidelines.
• Prepare for Investigator Meetings and sponsor meetings; support audit readiness and post-audit actions.
• Train site staff on applicable requirements and maintain ISF/TMF accuracy and archiving.
• Support subject recruitment, retention, and awareness activities; track observations and action items.
• Monitor project scope, budgets, and timelines; adapt to changing priorities to achieve objectives.

Kenntnisse

GCP knowledge

Regulatory knowledge

Communication skills

Teamwork

Ausbildung

Bachelor’s degree or RN

Tools

EDC systems

Jobbeschreibung

Overview In this role you will support single-sponsor clinical trials in Switzerland by monitoring sites to ensure regulatory, ICH-GCP, and protocol compliance. You will collaborate with site teams to manage data integrity, safety, and study documentation. You’ll work across remote and on-site activities, driving issue resolution and ensuring adherence to timelines. This is a patient- and data-centric position at a global contractor, offering exposure to diverse trials and cross-functional collaboration.

Leistungen / Benefits

• Total Self culture career development and progression technical and therapeutic area training peer recognition total rewards program

Verantwortungsbereiche

• Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) with regulatory and protocol compliance.
• Assess site processes, conduct source document review, and verify CRF data accuracy and completeness.
• Manage IP inventory, labeling, and storage considerations; ensure IP dispensing per protocol.
• Lead query resolution and recommend site actions to maintain data quality within CMP/SMP guidelines.
• Prepare for Investigator Meetings and sponsor meetings; support audit readiness and post-audit actions.
• Train site staff on applicable requirements and maintain ISF/TMF accuracy and archiving.
• Support subject recruitment, retention, and awareness activities; track observations and action items.
• Monitor project scope, budgets, and timelines; adapt to changing priorities to achieve objectives.

Zentrale Anforderungen

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
• Previous monitoring experience in Switzerland.
• Strong computer skills and ability to adopt new technologies.
• Excellent communication, presentation and interpersonal skills.
• Fluency in German and French; Italian is an asset.
• Ability to travel up to 75%.
• Excellent communication and interpersonal skills.
• Ability to adapt to changing priorities.
• Collaborative, cross-functional teamwork.
• ICH-GCP knowledge Regulatory knowledge Electronic data capture awareness.

Salary: EUR 59400 - 72600 per year