CRA Switzerland

Syneos Health Switzerland GmbH seeks a mid-level Clinical Research Associate (CRA) based in Zürich for a single sponsor partnership, primarily covering sites in Switzerland with occasional travel to Austria and Germany. The role involves monitoring clinical trials, ensuring compliance with GCP, regulatory standards, and protocol requirements.

This position supports a single sponsor partnership in Switzerland, focusing on clinical trial monitoring across local sites with limited travel to Austria and Germany. The CRA ensures regulatory and protocol compliance throughout all stages of the trial lifecycle.

Responsibilities

• Carries out site qualification, initiation, interim monitoring, management, and close-out visits, ensuring adherence to regulatory, ICH-GCP, GPP, and protocol standards.
• Assesses site and staff performance, reports critical issues to the project team, and helps develop corrective action plans.
• Stays current with ICH/GCP guidelines, local regulations, and company SOPs to maintain compliance.
• Verifies informed consent procedures and safeguards patient confidentiality.
• Evaluates factors impacting patient safety and data integrity, including protocol deviations and pharmacovigilance concerns.
• Reviews source documents and confirms clinical data accuracy and completeness in CRFs.
• Resolves queries remotely and on-site, guiding site staff to meet agreed timelines.
• Uses hardware and software tools for data review and capture, ensuring compliance with electronic data capture requirements.
• Manages investigational product inventory, reconciliation, storage, security, dispensing, and administration according to protocol.
• Applies GCP and local regulations to ensure proper (re)labelling, import, release, and return of investigational products.
• Reviews Investigator Site Files (ISF) for accuracy and completeness, and reconciles them with the Trial Master File (TMF).
• Documents monitoring activities through confirmation letters, follow-up letters, trip reports, and communication logs.
• Supports patient recruitment and retention efforts, entering data into tracking systems.
• Coordinates site-level activities and communication to meet project goals and timelines.
• Serves as primary contact for site personnel or collaborates with Central Monitoring Associates, ensuring staff training and compliance.
• Prepares for and attends Investigator Meetings, sponsor meetings, global clinical monitoring sessions, and training events.
• Guides sites toward audit readiness and supports audit preparation and follow-up.
• Completes required training assignments as assigned.

Requirements

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
• Understanding of Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements.
• Prior experience in clinical trial monitoring.
• Strong computer skills and openness to new technologies.
• Excellent communication, presentation, and interpersonal abilities.
• Fluent in German and French, with proficiency in English.
• Ability to manage required travel for monitoring activities.

About the company

Syneos Health is a leading biopharmaceutical solutions organization focused on accelerating customer success. The company integrates clinical, medical affairs, and commercial insights to address modern market needs, centering patients and customers in all activities. It emphasizes simplifying workflows, fostering innovation, and supporting employee development through training and rewards.

• The company prioritizes customer and patient focus in all operations.
• It simplifies and streamlines processes to make collaboration easier.
• Employees work alongside passionate problem solvers and innovators to help clients achieve goals.
• The organization is agile and committed to accelerating therapy delivery.
• It supports career development, training, and a total rewards program.
• It promotes a Total Self culture where employees can be authentic.
• It values diverse thoughts, backgrounds, cultures, and perspectives to foster inclusion.