Clinical Research Associate II

Job Description

Precision for Medicine, a CRO specializing in Oncology and Rare Diseases, is seeking a Clinical Research Associate II to join their team in Germany. The company prides itself on its culture and high CRA retention rates. This role offers the opportunity to focus on a limited number of studies, allowing for in-depth protocol expertise and a reasonable work/life balance. The CRA II will have a voice and impact within the company, benefiting from support from direct line management.

The Clinical Research Associate II will be responsible for site management and monitoring. They will work independently as a study team member.

Responsibilities include:

• Overseeing all aspects of study site management to ensure patient safety and data quality.
• Providing guidance at the site and project level towards audit readiness standards.
• Updating, tracking, and maintaining study-specific trial management tools and status reports.
• Managing site start-up procedures, including feasibility, IRB submissions, and regulatory document collection.
• Assisting in the negotiation of study budgets and the execution of investigator contracts.
• Verifying the informed consent process and assessing factors affecting patient safety and data integrity.
• Conducting site visits (pre-study, initiation, routine monitoring, and close-out).
• Preparing and submitting monitoring reports.
• Supporting patient recruitment and retention strategies.
• Reviewing the Investigator Site File (ISF) for accuracy and completeness.
• Communicating with site personnel and Precision Project and Clinical Trial Management.
• Performing investigational product (IP) inventory and reconciliation.
• Performing data review activities and resolving data discrepancies.
• Identifying and processing Serious Adverse Events.
• Identifying site risks and escalating them to the Clinical Trial Manager/Project Manager.
• Preparing for and attending Investigator Meetings and sponsor face-to-face meetings.

Requirements:

• University degree in life science, pharmacy, or a related health discipline.
• 1.5 years or more of experience as a CRA in a CRO or pharmaceutical/biotech industry.
• Site management or equivalent experience in clinical research.
• Excellent communication and organizational skills.
• Experience using computerized information systems.
• Ability to travel overnight (up to 60% on average).
• Fluency in English and the local language of Germany.

The role offers:

• Opportunity to work within Oncology and Rare Disease
• Reasonable travel
• Work/life balance