Senior Clinical Research Associate

Job Title: Senior Clinical Research Associate (Senior CRA)

Location: Multiple locations across Germany (Berlin, Munich, Frankfurt, Hamburg)

About Us:

Join a leading global Clinical Research Organization dedicated to advancing medical science through innovative research and development. We are committed to improving patient outcomes and delivering high-quality clinical trials. Our team of experts collaborates with top-tier pharmaceutical companies to bring cutting-edge therapies to market. As we continue to grow, we are seeking experienced and passionate Senior Clinical Research Associates (Senior CRAs) to join our dynamic team in Germany.

Position Overview:

As a Senior CRA, you will play a pivotal role in managing and monitoring clinical trials, ensuring compliance with regulatory requirements, and contributing to the development of life-changing therapies. You will be responsible for overseeing multiple study sites, maintaining the highest standards of data integrity, and fostering strong relationships with site staff and investigators.

Key Responsibilities:

• Conduct site qualification, initiation, monitoring, and close-out visits according to ICH-GCP guidelines, company SOPs, and regulatory requirements.
• Oversee all aspects of site management, including maintaining study files, liaising with vendors, and ensuring timely recruitment and retention of study participants.
• Ensure the protection of study participants by verifying adherence to informed consent procedures and protocol requirements.
• Perform thorough review and resolution of case report forms (CRFs), data queries, and adverse event reports.
• Provide mentorship and guidance to junior CRAs, fostering a culture of continuous learning and professional development.
• Act as the primary contact for site staff and investigators, addressing any issues or concerns promptly and effectively.
• Ensure audit readiness at the site level and assist with regulatory inspections as needed.

Qualifications:

• Bachelor's or Master's degree in a life science or related field.
• Minimum of 3-5 years of experience as a Clinical Research Associate, with a proven track record of managing and monitoring clinical trials in various phases.
• In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and SOPs.
• Strong organizational and time-management skills, with the ability to manage multiple priorities and meet deadlines.
• Excellent communication and interpersonal skills, with fluency in both German and English.
• Proficiency in using clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software.
• Willingness to travel extensively within Germany and occasionally internationally.

What We Offer:

• Competitive salary and comprehensive benefits package.
• Opportunities for career advancement and professional development.
• A supportive and collaborative work environment.
• The chance to work on innovative clinical trials that make a real difference in patients' lives.
• Flexible working arrangements, including remote work options.