Agnieszka Frankowska

Clinical Operations Leader, PAREXEL Polska sp. z o.o.
Otrębusy, mazowieckie

Języki

polski
ojczysty
angielski
biegły
serbski
biegły
hiszpański
podstawowy

Doświadczenie zawodowe

PAREXEL
Clinical Operations Leader
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.
PAREXEL
Senior Clinical Reasearch Associate
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.
PAREXEL
Clinical Research Associate
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.

Szkolenia i kursy

Clinical Lead Function and Responsibilities Detailed Training
Professional Skills Training: Improvement of the Management skills of long-term relationship with Investigator, Working Across Cultures, Professional Communication with Clients, Making Meetings Work.
Series of trainings on medical knowledge.
Ongoing CRA Training including Advanced CRA Trainings (Monitoring Informed Consent, Serious Adverse Events, Source Data Verification Practicalities, Effective Pre-study Visits, Regulatory Inspections, Project Speed, Shipment, Storage and Accountability of Test Article
Ongoing ICH GCP, local regulations and SOPs trainings.

Edukacja

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Emergency Medicine, studia podyplomowe
Warsaw School for Paramedics
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Filologia Słowiańska, magisterskie
Uniwersytet Warszawski
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Press and public relations, licencjackie
Warsaw Journalist Center

Specjalizacje

Badania i rozwój
Farmaceutyka/Biotechnologia
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Grupy

Uniwersytet Warszawski
Uniwersytet Warszawski
Uniwersytet Warszawski, założony w 1816 roku, jest największą polską uczelnią i jednocześnie jedną z najlepszych w kraju.