Report Reviewer
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Job Description
Central Report Reviewer reviewing clinical-trial documentation for patient safety, GCP compliance, and data integrity. Supporting monitoring teams at Syneos Health, a global life-sciences services organization.
Responsibilities:
- Execute Central Report Review activities on studies according to the monitoring strategy, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity
- Support development of annotated visit reports such as PSV, SIV, IMV, COV and SCAN
- Review the content and quality of site and central monitoring documentation, including site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence
- Document requested revisions and approvals in CTMS and ensure deliverables meet company and/or sponsor specifications and deadlines
- Assess factors affecting subject/patient safety and clinical data integrity, including protocol deviations, violations, sponsor requirements and pharmacovigilance issues
- Immediately communicate or escalate serious issues to the Clinical Trial Manager or Project Manager
- Document review observations and report protocol deviations or action items in appropriate systems
- Assess CRA/CM report quality, risks, trends and operational performance, and summarize findings for CTM review and action planning
- Participate in clinical monitoring/project staff meetings and clinical training sessions
- Maintain current project status knowledge through project discussions and email correspondence
- Support CTM activities such as Protocol Deviation management and Action Items management
Requirements:
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Capable of working in an international environment
- Previous clinical trial experience in site management and clinical preferred
- Preferred experience in study management, such as Lead CRA or equivalent
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good documentation habits and skills
- Strong attention to detail
- Good computer skills and ability to learn new technologies
- Good communication and interpersonal skills among project team and with sites
- Critical thinking and problem-solving skills
- Understanding of protocol, SOPs, ICH GCP and country regulations
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations for applicants with disabilities, when appropriate
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