Senior Clinical Research Associate

This is a fully remote position, open to applicants in Germany.

📋 Description

• Carry out clinical monitoring tasks at clinical trial locations following ICH guidelines, GCP, local laws, and standard operating procedures (SOPs).

• Conduct site selection and assessment while supporting recruitment objectives.

• Deliver protocol and study training to designated sites.

• Perform onsite and remote pre-study, initiation, routine monitoring, and closeout visits.

• Execute co-monitoring visits as necessary.

• Compile visit reports, follow-up letters, action plans, and other related study documentation.

• Oversee site performance by tracking regulatory submissions, recruitment progress, CRF completion, and resolving data queries.

• Maintain documentation for the Trial Master File and Investigator's Site File, ensuring readiness for inspections.

• Communicate site progress, challenges, and recommended actions to Clinical Operations.

• Collaborate with Country and Regional Clinical Study Managers and clinical study sites to achieve study milestones.

• Organize compliance visits, site audits, and inspections.

• Assess site quality and integrity, escalating GCP concerns as needed.

• Recognize site issues, suggest corrective and preventive measures, and drive operational excellence.

• Mentor junior team members and serve as an escalation point for site-related concerns.

• Review visit reports, track issue resolution, and communicate significant risks along with recommended actions.

• Act as a subject matter expert in clinical operations, country regulations, and monitoring activities when required.

⛳️ Requirements

• Bachelor's degree in a scientific or healthcare field is preferred.

• A minimum of 3–5 years of monitoring experience.

• Over 5 years of CRA monitoring experience in the pharmaceutical or CRO industry.

• A relevant combination of education, training, and experience may also be considered.

• Advanced understanding of clinical research regulatory requirements, including GCP and ICH guidelines.

• Experience in oncology/onco-hematology trials is preferred.

• Strong communication and interpersonal skills.

• Capability to build and sustain effective working relationships with colleagues, managers, and both internal and external stakeholders.

• Excellent organizational and problem-solving abilities; adept at prioritizing and multitasking.

• Effective time management capabilities.

• Proficient in English and German.

• Skilled in Microsoft Word, Excel, PowerPoint, Outlook, as well as using a laptop computer and iPhone.

• Willingness to travel up to 80% of the time.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and training.

• Flexible work arrangements.

• Supportive and collaborative work environment.