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

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

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

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

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.

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

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