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Clinical Research Associate - Bulgaria - Permanent
Posted by: Clinical Professionals
Posted date: 2012-Feb-07
Location: Sofia
Clinical Research Associate - Bulgaria - Permanent
Excellent salaries being paid
Our client is a global CRO with a focus on delivering efficiency and consistent value in all that they do. The organisation deal with a good variety of trials, from large complex global studies through to smaller, regional trials. Through their global reach and therapeutic expertise this company have fostered the development of highly successful partnerships with their sponsor organisations
Job Summary
Monitoring for Phase I-IV clinical research studies while developing an understanding of the drug development process, GCP, and relevant regulations. Provide clinical and technical support for junior CRAs and CTAs. Management of study site activities and ensure adherence to regulatory guidelines and SOPs
Key Duties
• Performs feasibility, pre-study site visits, study start-up, clinical trial initiation, monitoring and close out activities in accordance with regulations and SOPs.
• Develops new approaches for site selection, and pre-study activities and completes site evaluation
• Completes submission of documents to the Ethics Committees and tracks regulatory documents. Manages investigator grants.
• Develops monitoring plan, CRFs, and other study related documents.
• Preparation and coordination of investigator meetings and attends when required.
• Develops patient enrollment strategies.
• Ensures proper storage, dispensation, and accountability of all Investigational Products
• Completes study site closeout visits and study site evaluation
Skills and Education:
RN, BSc or equivalent
At least 1-2 years clinical trial monitoring experience
Good command of written and spoken English and Bulgarian (essential).
Ability to travel domestically and internationally as required
If this opportunity is of interest please contact Ed Bezer +44 207 822 1710 ed.bezerclinicalprofessionals.eu
Clinical Professionals is an equal opportunities employer. Please only apply to this opportunities if you are legally able to live and work in Bulgaria and have the required linguistic ability as these are essential to the role.
Key Words: CRA SCRA Clinical Research Associate Clinical Monitor Clinical Development Clinical Study Start Up Clinical Trial Specialist Permanent Sofia Bulgaria Research and Development Pharmaceutical Development Clinical Research Organisation CRO