Freelance Senior Clinical Research Associate
On-sitePrague, Prague, Czechia
Job Summary
Monitor on-site and remotely clinical trials in accordance with GCP and ICH guidelines to assess subject safety, data integrity, and protocol compliance. Verify informed consent procedures, review CRFs and source documentation for accuracy, and ensure proper management of investigational products. Provide unmasked CRA support by reporting findings, escalating deficiencies, and delivering documents to TMF systems. Participate in audit preparations, order investigative supplies, and assist with project tracking and CRA resource management. Act as a mentor to CRAs and develop therapeutic area training. This freelance role within the Ophthalmology team requires 5+ years of independent monitoring experience, fluency in English and Czech, and up to 60-80% travel.
Required Qualifications
- Bachelor's Degree, preferably in life science or nursing; or equivalent
- >5 years of independent on-site monitoring experience
- at least 1 year experience as an unmasked monitor
- Able to work in a fast-paced environment with changing priorities
- Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines
- Ability to work independently as well as in a team matrix organization
- Excellent written and verbal communication skills
- Fluent in English and local language
- Excellent organizational skills
- Technology savvy and good software and computer skills
- Self-awareness
- resolute
- flexibility
- collaborative mindset
- proactivity
- analytic approach
- attention to detail
- coach ability
- motivated to take on new challenges
- facilitation of discussion
- diplomacy in difficult situations
- Ability to take the ownership of the assigned tasks
- Ability to manage complex or early phases studies
- Ability and willingness to travel up to 60-80%, overnight and abroad, if applicable
Desired Qualifications
- At least 1 year Ophthalmology, ideally within a retina indication (i.e. Age-related Macular Degeneration, Diabetic Macular Edema, Geographic Atrophy, RVO, BRVO, CRVO, etc.), experience is preferred
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