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Sr CRA (Level II)
Remote · Bulgaria
Job Summary
Senior Clinical Research Associate (Level II) coordinates and performs remote and on-site clinical monitoring and site management to ensure protocol compliance and regulatory adherence (ICH-GCP, SOPs). Responsibilities include SDV/CRF review, regulatory documentation, sponsor communications, risk-based monitoring, and mentoring junior team members. Travel is frequent (approximately 60-80%), with potential site visits and on-site activities. Requires a life-science degree or RN and 3+ years of relevant experience. Applies knowledge of FDA guidelines and clinical trial processes to maintain data integrity and subject safety.
Required Qualifications
- Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor)
- Valid driver's license where applicable
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