Senior Clinical Research Associate (CRA II) (mfd)

At Vivalyx a medical technology startup based in Cologne were on a mission to save the lives of those suffering from organ failure. Our innovative approach aims to dramatically improve the vitality and availability of donor organs. As we gear up for certification and related studies were seeking dedicated team members (m/f/d) permanent or contractor to join us starting as soon as possible for 32-40 hours per week.

We provide the opportunity to work on groundbreaking technology that has a meaningful impact. Youll be part of a dynamic highly skilled and motivated team. We prioritize flexibility offering mobile working conditions and a flat hierarchical addition we support professional development and career growth along with an attractive employee participation program.

We are looking for a passionate and experienced Senior Clinical Research Associate to take operational ownership of site management and clinical monitoring across clinical studies.

This is a hands-on role for someone who is comfortable monitoring studies directly building trusted relationships with investigators and coordinators and managing several small to mid-sized trials in parallel. Studies may be conducted in Europe the United States or both.

• Act as Vivalyxs primary operational contact for investigators and study coordinators.
• Prepare conduct and document site initiation interim on-site and remote monitoring and closeout visits.
• Perform source data review and verification.
• Track study progress enrollment follow-up visits data-entry status queries protocol deviations and training needs.
• Review and follow up adverse events adverse device effects and device deficiencies.
• Maintain the TMF and support database-lock audit and inspection readiness.
• Proactively identify risks resolve operational issues and escalate when needed.
• Collaborate with cross-functional teams sites and CROs to ensure successful study delivery across multiple parallel studies.

• 2 years of CRA experience preferred including direct on-site monitoring.
• Experience with medical-device clinical investigations is preferred.
• GCP and ISO 14155 experience required.
• Working knowledge of ICH-GCP required.
• Ability to manage multiple studies and priorities independently in a fast-moving startup environment.
• Clear pragmatic communicator who can work confidently with investigators coordinators CROs and internal stakeholders.
• Willing and able to travel regularly within Europe and to the United States.
• Fluent in English both written and spoken (German is a strong plus).

• Company car
• Public transport ticket (Deutschlandticket Job / JobTicket)
• Urban Sports Club membership
• Flexible mobile working arrangements and flat hierarchies
• Regular opportunities or training and professional development
• Employee stock option program

We look forward to hearing from you.