Skills

  • Education
  • Healthcare
  • Management
  • Project Management

Recommendations

Judy Arego

 7/18/2023
10

"Rose is very liable, a team player, very keen and pays attention to details she is one person who is very flexible to work with and she settles for nothing but the best. Rose is result oriented and i would highly recommend her for a position."

Experience

abwunza rose

Work experience
  • Reviewing protocols and determining site’s capability to participate in (in terms of population vs demographic characteristics, sample size determination vs disease burden, general infrastructure-laboratory, pharmacy capacity)
  • Participates in site selection and site initiation meetings
  • Conducting internal audits/ internal monitoring as per Clinical Quality Management Plan (CQMP). Singe designated staff who performs internal audits and internal inspections for the studies twice a year.
  • Responsible for creation of QA related SOPs, reviewing applicable CRS SOPs and approving applicable SOPs and responsible for tracking calibration timelines for equipment and maintains documentation including SOP. Ensuring all SOPs are tracked and periodically reviewed. Conducting biannual audit on SOPs to assure compliance.
  • Conducting, coordinating and facilitating trainings
  • Following up of identification of adverse events, reporting and linking with study endpoints
  • Monitoring site’s data performance and working with the teams to ensure that the network metrics are met and action plans done and implemented to the latter.
  • Collating reports from various sections such as the lab, QA and Regulatory and submitting to the sponsor in a timely manner
  • Contact communications person between the site and the external collaborators on site specific issues
  • Coordinating internal broad meetings with general staff, senior staff, core staff and those involving the external collaborators;
  • Preparing updates for site calls and participating in the calls
  • Collating monthly reports from different sections and submitting to the network in a timely manner.
  • Preparation and execution of budgets
  • Performing Inspections and audits twice a year for CRS studies
  • Assuring compliance with regulatory, International Council for Harmonization, Good Clinical Practice (ICH-GCP) and protocol requirements through Daily quality checks on source data and Source data verification.
  • Trouble shooting and helping solve project related challenges and instituting measures for prevention of recurrence of these issues.
  • Checking for identification and timely reporting of Adverse events and clinical endpoints.
  • Preparing site for external monitoring visits, and following up on external monitoring findings to closure.
  • Responsible for tracking source documents, case report form completion and submission, and data query generation and resolution.
  • Guiding the study team to ensure compliance with CQMP, study specific SOPs, protocols and any other guiding documents.
  • Generating biannual Quality Assurance summary reports and submitting them to the Division of AIDS (sponsor) network and instituting and monitoring CAPAs where necessary.
  • Interface between the laboratory, pharmacy and the clinic with regards to QA/QC activities
  • Responsible for coordination and facilitation of study specific trainings and general trainings, and maintaining electronic and hard copy records of the training materials (as applicable) and documentation including tracking of trainings.
  • Consistency and logically checks on the source documents completed by the clinicians for completeness and accuracy of information
  • Follows up to ensure adverse events and serious adverse events are properly documented and reported in a timely manner.

Related persons

Judy Arego

 7/18/2023
10

"Rose is very liable, a team player, very keen and pays attention to details she is one person who is very flexible to work with and she settles for nothing but the best. Rose is result oriented and i would highly recommend her for a position."