Kourtnei James Email & Phone Number

Durham, North Carolina, United States

In collaboration with CEC faculty, identified specific adjudication criterion for event classification.• Collected source documentation to support clinical adverse event adjudication.• CRF review and query resolution using EDC, metrics tracking in CTMS• Contributed to development of protocol, ICFs, study manuals, and eCRF design.• Performed review of adjudication to assure consistent application of endpoint definitions.• Dossier preparation and review• TMF – Set-up, maintenance, and audit/inspection activities; review of study documents including site monitoring reports, site start up documentation, classifying, indexing, and archiving of clinical documentation; Conducted internal QC of eTMF and collected missing or expired essential documents from sites.• Presentations in project team meetings and investigator meetings

Morrisville, North Carolina, United States

Client-facing, Team Lead• Responsible for day-to-day activities of the PV team, managing resources, workload quality and metrics; scheduling and facilitating team meetings, drafting minutes, ensuring project timelines and deliverables met.• Assisted with performance reviews, coaching, and mentoring to staff.• Budgeting, forecasting, Bid Defense, Contract Modification• Tracking of KPIs and internal metrics; risk management trackers, Signal detection.• CAPA deviation QEI oversight• Aggregate reports (ICSR, DSUR, FDA IND, PSUR, Line Listings)• Audit /Inspection preparation, eTMF document review and maintenance; close-out• Study start-up; Safety database set-up, validation/user acceptance testing (UAT)• SUSAR expedited reporting/regulatory submissions -literature review, AOSE, global regulatory authorities, E2B validations, electronic IND and NDA submissions.• Authoring/drafting of SMP, SOPs, WPs• Periodic reconciliation of safety and clinical databases

Durham, North Carolina, United States

• In collaboration with CEC faculty, identified specific adjudication criterion for event classification.• Collected source documentation to support clinical adverse event adjudication.• CRF review and query resolution using EDC, metrics tracking in CTMS• Contributed to development of protocol, ICFs, study manuals, and eCRF design.• Performed review of adjudication to assure consistent application of endpoint definitions.• Dossier preparation and review• TMF – Set-up, maintenance, and audit/inspection activities; review of study documents including site monitoring reports, site start up documentation, classifying, indexing, and archiving of clinical documentation; Conducted internal QC of eTMF and collected missing or expired essential documents from sites.• Presentations in project team meetings and investigator meetings

Durham, North Carolina, United States

Client-facing, Team Lead• Responsible for day-to-day activities of the PV team, case processing, workload quality and metrics; scheduling and facilitating team meetings, drafting minutes, ensuring project timelines and deliverables met.• Managed safety email inbox including archiving of emails and documents.• Managed SAE processing workflow and submission trackers; Team QC of data• Study start-up; Safety database set-up, validation/user acceptance testing (UAT)• Audit /Inspection preparation, eTMF document review and maintenance; close-out• SUSAR expedited reporting/regulatory submissions -literature review, AOSE, global regulatory authorities, E2B validations, electronic IND and NDA submissions.• Authoring/drafting of SMP, SOPs, WPs• Aggregate reports (ICSR, DSUR, FDA IND, PSUR, Line Listings)• Periodic reconciliation of safety and clinical databases

Morrisville, North Carolina, United States

• SAE/AE review and case management including intake, duplicate check, triage assessment of seriousness and expectedness, data entry, and narrative writing.• Review of clinical trial data collection/medical records/ central labs• SUSAR expedited reporting/regulatory submissions -literature review, AOSE, global regulatory authorities, E2B validations, electronic IND and NDA submissions.• QC review of data entry• Query review and resolution• Periodic reconciliation of safety and clinical databases

Durham, North Carolina, United States

Specialty was ICU/CCU/ED + Float (Med Surg/Telemetry/PACU); management of critically ill patients including ventilators, hemodynamic monitoring, IV titration, CABG post op, Cath Lab, PACU, CVVH dialysis, Oncology (IV chemo admin and port access); strong venipuncture. management duties of unit, staffing and scheduling; administrative duties in absence of manager (ACLS, BLS, PALS); EPIC

Master Of Business Administration (M.B.A.), Health/Health Care Administration/Management

Bachelor Of Science (B.S.), Registered Nursing/Registered Nurse