Syneos Health job vacancy for Central Report Reviewer || Apply Now
Central Report Reviewer
Description:
Central Report Reviewer
Job responsibilities:
Responsible for execution of Central Report Review activities on the study based on the
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 assesses 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.
Qualifications:
What we’re looking for
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Should have 5+ years in Clinical Operations in Global CRO or Global Pharma.
Should have 3+ years of CRA experience with on-site activities and PSSV, SIV, IMV, COV reports writing
Having experience in phases II-III multicenter studies is preferred
Must have worked on PSSV, SIV, IMV, COV reports review experience.
Should have Good GCP knowledge
Knowledge and experience in Medidata CTMS and Veeva TMF is a Plus
Previous clinical trial experience in site management and clinical preferred
Preferred experience in study management (as Lead CRA of 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
APPLY NOW
