Skip to main content
McCarthy Search

CRA II/Sr CRA - Sponsor-Dedicated FSP - Germany (m/f/d)

L5

thermo fisherDenver, COyesterday

Occupations

Clinical Research CoordinatorsRegulatory Affairs SpecialistsRegulatory Affairs Managers

Industries

Research and Development in the Physical, Engineering, and Life SciencesOther Scientific and Technical Consulting ServicesResearch and Development in Biotechnology
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 LifeReview 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 now (opens in a new tab)
Apply now (opens in a new tab)

Level

SeniorL5

Location

Denver, CO

Occupation

Clinical Research Coordinators

Industry

Research and Development in the Physical, Engineering, and Life Sciences

Posted

yesterday

To get sharper similar jobs, create your profile using the link below.

Create profile