Clinical Research Associate (m/w/d)

The Clinical Research Associate supports the Global Clinical Operations Center of Excellence by helping to build - in partnership with business units - a world-class shared clinical technology, process innovation and clinical operations team through technological enablement, direct customer service, Study acceleration and high-quality data collection.

Tasks:

-Source verification: Matching case report form data with source documents, reviewing informed consent forms (ICFs) and regulatory documents and product stewardship records

-Communication: Ensuring clear communication with clinical sites and project team members, including through monitoring reports, follow-up letters and study memos

-Training: Ensuring adequate training of all staff to conduct the clinical trial in accordance with the study plan and applicable regulations

-Compliance: Ensuring compliance with regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal standard operating procedures, policies and procedures

-Escalation Processes: Ensuring clear communication, documentation and resolution of identified non-compliance issues at the site, as well as supporting internal quality audits and regulatory inspections

-Event Reporting: Ensuring identification, clear documentation and reporting of all reportable events in accordance with the audit plan and applicable requirements and regulations

-Collaboration: Participate in study-specific meetings, conference calls, and training sessions, and collaborate with cross-functional team members and study sites during all study phases

-Documentation: Manage study contracts, request relevant investigator/site documentation, and review documents in the appropriate database

-Site commissioning: Coordinating all activities necessary for the submission of regulatory applications and the collection of essential documents, as well as working with the clinical centers to support the negotiation and adjustment of the ICFs

-Schedule Monitoring: Achieve target EC schedules by assisting clinical research sites with the submission process and tracking approvals

Profile:

• A successfully completed business administration (technical) university degree or a successfully completed commercial training with appropriate professional experience or

• Several years of experience working in clinical research and clinical field monitoring

• Strong communication and presentation skills and confident interaction with clinical research facility staff

• Team player with high social skills, empathy and communication at eye level

• Fluent knowledge of German, French and English, both spoken and written.

· Experience in Oncology and Pharma studies.

Willingness to travel in the above region with residence in Switzerland as well as occasional

travel to France, Austria and Germany.