CRA II/Sr CRA - Sponsor-Dedicated FSP - Germany (m/f/d) 2026-09-18 Thermo Fisher all cities,

AK Description:

Clinical Research Associate This position is for experienced Clinical Research Associates with 2+ years of independent monitoring experience. You will manage clinical trial sites across Germany, ensuring studies are conducted in compliance with the protocol, ICH-GCP, applicable regulations, and company SOPs. You'll work autonomously, partner closely with investigative sites, and collaborate with project teams to deliver high-quality, inspection-ready clinical trials. What You'll Do Perform site monitoring activities (on-site and remote) using a risk-based monitoring approach Ensure protocol, ICH-GCP, regulatory, and SOP compliance at investigator sites Conduct

SDR, SDV, CRF

review, and investigational product accountability Identify, document, escalate, and follow up on issues through resolution, applying root cause analysis and CAPA principles Maintain audit and inspection readiness at all assigned sites Build strong, collaborative relationships with investigators and site staff Document monitoring activities in timely, high-quality reports and follow-up letters Maintain ongoing communication with sites between visits to support issue resolution and data quality Ensure study systems (e.g., CTMS) are updated according to study conventions Provide trial status updates and metrics to the Clinical Team Manager (CTM) Support study start-up, investigator identification, site initiation, and study close-out activities as assigned Participate in investigator meetings, audits, inspections, and project team meetings as required Additional responsibilities may include supporting process improvement initiatives, mentoring activities, or project-specific tasks aligned with experience. A Day in the Life Review site metrics and prioritize monitoring activities based on risk Conduct on-site or remote monitoring visits Partner with sites to resolve findings and improve processes Collaborate with CTMs and project teams to keep studies on track and inspection-ready Complete documentation, system updates, and administrative tasks Education & Experience Bachelor's degree in a life sciences related field or equivalent qualification Minimum 2 + years of experience as a Clinical Research Associate / Monitor Valid driver's license Full right to work in Germany Fluency in German and English (C1 level) - interviews will be conducted in English & German Knowledge, Skills & Abilities Strong clinical monitoring skills with hands-on RBM experience Excellent understanding and application of ICH-GCP and applicable regulations Solid therapeutic area knowledge and medical terminology Well-developed critical thinking, problem-solving, and root cause analysis skills Strong written and verbal communication skills with medical professionals High attention to detail and strong organizational skills Ability to work independently while contributing effectively to cross-functional teams Flexibility and adaptability in a dynamic project environment Proficiency in Microsoft Office and ability to learn clinical systems (e.g., CTMS)

Locations:

Home-based or hybrid anywhere in

Germany FTE:

Full-time (40 hrs/week)

Contract:

Permanent Travel:

Approximately 50-75% (study-dependent) Apply for this Job Please use the

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