Jobs at Syneos Health

The Central Report Reviewer (CRR) has the overall responsibility for execution of Central Report Review activities on an assigned study. The Central Report Reviewer performs report reviews and approves reports for Phase I-IV clinical research studies to assess compliance with the protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements as well as ensure patient safety and data integrity using a variety of technologies. In addition, the CRR ensures that any trip report fully reflects conducted monitoring activity, and report finalization timelines are compliant with SOP, regulatory guidelines and Monitoring Plan. Will use analytical skills, critical thinking, data and information analysis, research and communication to problem solve. Performs all tasks routinely and independently.

• Monitoring strategy defined, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• May support development of annotated visit reports such as PSV, SIV, IMV, COV & SCAN.
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations/special Sponsor's requirements and pharmacovigilance issues documented in the report. Immediately communicates/escalates serious issues to Clinical Trial Manager/Project Manager.
• Documents observations noted during reviews and ensures protocol deviations or action items are reported as necessary in appropriate systems for action by CRA/CM or other functional team members.
• May assess CRA/CM report quality, risks, and trends as well as operational performance and summarizes the findings for CTM review and action planning.
• Participates in clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements. Involves in regular project discussion and email correspondence to maintain the most up-to-date project status knowledge and progression.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
• May support in CTM activities such as Protocol Deviation management, Action Items management, etc.

• 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 (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
• Must demonstrate good computer skills and the ability to learn new technologies
• Good communication and interpersonal skills among project team and with sites
• Demonstrates critical thinking and problem solving techniques to determine the cause and appropriate solution in the identification of issues