CRA II Sr CRA in Spain Full Service Single Sponsor at Syneos 2022

CRA II Sr CRA in Spain Full Service Single Sponsor

responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.  Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.  Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Additional Information:

asks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. 

CRA II Sr CRA in Spain Full Service Single Sponsor at Syneos 2022

About: Syneos

Syneos Health established the Trusted Process more than a decade ago as a disciplined methodology for planning, problem solving and execution. It acts as the enterprise-wide framework for delivery excellence that underpins BAM. The Trusted Process is repeatable, predictable, highly reliable and has been proven in our clinical practices to meet critical development milestones faster than the industry average. That’s why it is rapidly being expanded across the entire spectrum of Syneos Health solutions to optimize engagement of medical and patient communities after product approval.

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