Senior Clinical Research Associate – FSP Oncology
Job reputed company:
• Monitors investigator sites with a risk-based monitoring approach: applies reputed company cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Documents observations in reports and letters in a reputed company manner using approved business writing standards.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Ensures a shared responsibility with other project team members on issues/findings reputed company.
• Investigates and follows-up on findings as applicable.
• Provides trial status tracking and reputed company update reports to the Clinical Team Manager (CTM) as required.
• Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).
• Performs QC reputed company of reports generated from CTMS system where required.
• Participates in investigator meetings as necessary.
• Insures trial reputed company out and retrieval of trial materials.
• Ensures that required essential documents are complete and in reputed company, according to ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing reputed company/suggestions with team members.
Requirements:
• Bachelor's degree in a life sciences reputed company field or a Registered Nursing certification or equivalent and relevant formal reputed company / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 2+ years as a clinical research monitor).
• reputed company reputed company's license where applicable
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role.
Benefits:
• Health insurance
• Retirement plans
• reputed company time off
• Flexible working hours
• reputed company development
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