Warsaw, Mazowieckie, Poland
Tough not cooperating sites, Hudge SDV backlog just before DBL, ISF to reconcile before audit, who you gonna call?.....me😉 More than 13 years experienced Freelance Senior Clinical Research Associate with a demonstrated history of working in the pharmaceuticals industry. Skilled in all types of monitoring visits, site management, skilled Multi-tasker with a Master of Pharmacy degree and Medical Doctor degree from Medical Academy Warsaw (Medical University of Warsaw). Available for freelance contracts now.
• Responsible for Atopic Dermatitis study. • Clinical monitoring including initiation, monitoring and close-out as well • Arranging and coordinating site/sponsor equipment shipments • ISF/TMF QC and documents filing • Ongoing site documents preparation and collection regulatory documents • Patient Reported Outcomes review • Participation in database locks
• Responsible for Rheumatoid Arthritis study with challenging SDV workload. SDV targets met. Close out visits. • Responsible for Brest Cancer study including Site Initiation Visits • Co-monitor/backup CRA in lower limb spasticity study • Clinical monitoring. • ISF/TMF QC and documents workflow • Ongoing site documents preparation and collection regulatory documents • Patient Reported Outcomes review • Participation in database locks achieving timelines
• Responsible for two Atopic Dermatitis study with challenging SDV workload. SDV targets met. • Clinical monitoring including initiation, monitoring and close-out as well • Arranging and coordinating site/sponsor equipment shipments • ISF/TMF QC and documents filing • Ongoing site documents preparation and collection regulatory documents • Patient Reported Outcomes review • Participation in database locks achieving timelines
Responsible for Atopic dermatitis study with challenging SDV workload. SDV targets met. Responsible for Peripheral T-cell Lymphoma study with challenging recruitment due to rare disease. Responsible for pediatric migraine. Responsible for Cerebral Palsy study. Clinical monitoring including initiation, monitoring and close-out as well Arranging and coordinating site/sponsor equipment shipments ISF/TMF QC and documents filing Ongoing site documents preparation and collection regulatory documents Patient Reported Outcomes review
Responsible for paediatric spinal muscular atrophy study with challenging COVID site management Responsible for Osteoarthritis study with challenging large amount of patients and COVID site management. SDV targets met. Clinical monitoring including remote and regular monitoring visits, sites remote trainings Preparation for audits ISF/TMF QC and documents filing Ongoing site documents preparation and collection regulatory documents Patient Reported Outcomes review