Job Description
Accelerate the Future of Medicine with MediCore Therapeutics
MediCore Therapeutics AG is a leader in developing breakthrough therapies for rare diseases. We are currently seeking a Senior Clinical Research Associate (CRA) to join our dynamic Clinical Operations team in Zurich. In this high-impact role, you will oversee the clinical development lifecycle of our next-generation pharmaceutical products, ensuring that our trials meet the highest standards of scientific rigor and patient safety.
We are looking for a self-driven professional who thrives in a fast-paced environment and is passionate about bringing life-changing treatments to patients worldwide. If you possess the expertise to navigate complex regulatory landscapes and lead cross-functional teams, this is your opportunity to shape the standard of care.
Responsibilities
- Site Management & Monitoring: Lead the initiation, execution, and close-out of clinical trials at investigational sites across the EMEA region, ensuring adherence to protocol and regulatory guidelines.
- Regulatory Compliance: Conduct rigorous monitoring visits to verify compliance with ICH-GCP, Good Clinical Practice, and local regulatory requirements (e.g., Swissmedic, EMA).
- Data Integrity: Oversee the management of Source Data Verification (SDV) and ensure the accuracy, completeness, and timeliness of clinical data entry into Electronic Data Capture (EDC) systems.
- Stakeholder Liaison: Act as the primary point of contact between the Sponsor, Contract Research Organizations (CROs), and Principal Investigators, fostering strong professional relationships.
- Adverse Event Reporting: Monitor and report Adverse Events (AEs) and Serious Adverse Events (SAEs) in strict accordance with safety reporting timelines (SUSARs).
- Problem Solving: Identify and mitigate risks to trial timelines and budgets, implementing effective corrective action plans when deviations occur.
Qualifications
- Education: Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field (PhD or PharmD preferred).
- Experience: Minimum of 4-6 years of experience as a Clinical Research Associate, preferably within a biotechnology or pharmaceutical setting.
- Certification: Current GCP certification (e.g., RAC or CIP) is highly desirable.
- Technical Proficiency: Extensive experience with CTMS (Clinical Trial Management Systems) and EDC systems (e.g., Medidata Rave, Oracle Clinical).
- Languages: Fluent in English (written and verbal) and German (written and verbal) is mandatory.
- Soft Skills: Strong analytical thinking, exceptional communication skills, and the ability to work effectively under pressure in a global team environment.