Clinical Research Associate - FSP - Czechia
RemoteCzechia
Job Summary
Monitor investigator sites using a risk-based approach, applying root cause analysis to identify process failures and implement corrective actions. Ensure data accuracy through SDR, SDV, and CRF reviews while conducting on-site and remote monitoring activities. Manage procedures for different sponsors and environments, ensuring trials comply with ICH-GCP guidelines, approved protocols, and SOPs. Initiate clinical trial sites, conduct file reviews, and facilitate communication between investigative sites, the client company, and the project team. Respond to regulatory requirements and audits, maintaining audit readiness and tracking study progress for the Clinical Team Manager.
Required Qualifications
- Bachelor's degree in a life sciences related field
- Registered Nursing certification
- equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- comparable to 1 years as a clinical research monitor
- completion of PPD Drug Development Fellowship
- Valid driver's license
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs
- applicable regulations
- procedural documents
- Well-developed critical thinking skills
- critical mindset
- in-depth investigation for appropriate root cause analysis
- problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills
- ability to communicate effectively with medical personnel
- Ability to maintain customer focus
- good listening skills
- attention to detail
- ability to perceive customers' underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Good computer skills
- solid knowledge of Microsoft Office
- ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
- Ability to work in a team or independently as required
- Ability to remain flexibile and adaptable in a wide range of scenarios
- Frequent travel, generally 60-80%
- extended overnight stays
- exposure to biological fluids
- potential exposure to infectious organisms
- Personal protective equipment
- protective eyewear
- garments
- gloves
- exposure to fluctuating and/or extreme temperatures
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