Central Report Reviewer

Job Responsibilities

• Execute Central Report Review activities on the study based on the Monitoring strategy defined, focusing on patient safety, protocol/GCP/regulatory compliance, and data integrity.
• Support the development of annotated visit reports such as PSV, SIV, IMV, COV & SCAN.
• Review 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 convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.
• Document requested revisions and approvals in CTMS.
• Ensure these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Afford assessments of 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 communicate/escalate serious issues to Clinical Trial Manager/Project Manager.
• Document observations noted during reviews and ensure protocol deviations or action items are reported as necessary in appropriate systems for action by CRA/CM or other functional team members.
• Assess the quality, risks, and trends of CRA/CM reports and operational performance, summarizing findings for CTM review and action planning.
• Participate in clinical monitoring/project staff meetings and attend 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.

Qualifications

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.