Agnieszka Frankowska

Responsibilities:
• Coordination of the clinical activities on international multicenter trials from project initiation to close out of the trial,
• Proactive identification of potential problems and timely action to correct or alleviate the issues.
• Plan, schedule and regularly review study activities to ensure deliverables are met.
• Interact with client and team leadership to ensure that projects proceed on time and within budget.
• Participate and organize meetings with client, study team, investigators and other applicable vendors and CROs.
• Manage study budgets, financial tracking and control ensuring both the client, company and study sites requirements are being met.
• Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project.
• Provide mentoring to direct reports including CRAs to ensure that the best quality can be achieved.

Clinical trials monitoring in accordance with the ICH Guidelines, the current monitor guidelines and SOP’ s including identifying sites, preparing documentation for necessary approvals, initiating sites and observing recruitment, performing monitoring at sites, quality control review of data collected during monitoring visits, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting Case Report Forms, following up and solving data queries, reporting the progress of the study on a regular basis and performing site close-out visits.

Senior Clinical Research Associate responsibilities included also mentoring for study team, conducting co-monitoring and training visits for junior team members and helping Clinical Lead and Project Manager with design of study tools, documents and processes.

Clinical Lead responsibilities included reporting the study progress to the Sponsor, coordination of work in different departments involved to the study, performing of study team trainings, organization and leading of the teleconferences, approving of Investigators and Hospitals payments, reviewing of site qualification/initiation/monitoring/termination visit reports.

Clinical trials monitoring in accordance with the ICH Guidelines, the current monitor guidelines and SOP’ s including identifying sites, preparing documentation for necessary approvals, initiating sites and observing recruitment, performing monitoring at sites, quality control review of data collected during monitoring visits, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting Case Report Forms, following up and solving data queries, reporting the progress of the study on a regular basis and performing site close-out visits.