Job Title: Clinical Research Associate II (CRA II)
Location: Germany (Travelling 6-8 times per week)
Department: Clinical Operations
Job Summary
The Clinical Research Associate II (CRA II) is responsible for independently monitoring clinical trial sites to ensure compliance with study protocols, ICH-GCP guidelines, and applicable regulatory requirements. The CRA II acts as the primary point of contact for investigative sites and plays a key role in ensuring data integrity, patient safety, and timely study execution.
Key Responsibilities
* Perform all types of site monitoring visits (selection, initiation, routine, and close-out)
* Ensure trials are conducted in accordance with protocol, ICH-GCP, and local regulatory requirements (e.g., German regulatory authorities such as BfArM/PEI)
* Verify source data and ensure accuracy, completeness, and consistency of clinical trial data
* Identify, document, and follow up on site issues, including protocol deviations
* Maintain regular communication with investigators and site staff
* Support site training and ensure proper study documentation and filing (e.g., ISF/TMF)
* Track study progress and provide regular status updates to project teams
* Assist in regulatory submissions and ethics committee interactions when needed
* Ensure patient safety is protected and adverse events are properly reported
Qualifications & Experience
* Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field
* 2–4 years of CRA experience in clinical trials (monitoring experience required)
* Strong knowledge of ICH-GCP and EU clinical trial regulations
* Experience with oncology, rare disease, or other therapeutic areas (preferred but not mandatory)
* Fluent in German and English (written and spoken)
* Willingness to travel within Germany (typically 50–70%)
Skills & Competencies
* Strong organizational and time-management skills
* Excellent attention to detail and problem-solving ability
* Effective communication and interpersonal skills
* Ability to work independently and in a team environment
* Proficiency with clinical trial systems (e.g., EDC, CTMS)
What We Offer
* Competitive salary and benefits package
* Flexible working arrangements (home-based options)
* Career development and training opportunities
* International and collaborative work environment