Katarzyna Salbut-Kaplanska

Countries handled: Australia (45 sites), South Korea (39 sites), Taiwan (18 sites), Hong Kong (2 sites), India (19 sites), Malaysia (4 sites); 12 projects. Member of RCTM forum, SMA in eTMF; P

• Study stages handled: Study start-up, Monitoring, Study Closeout ; phase I-IV
• Leading regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with global study project plan
• Identifying and resolving issues at regional level
• Collaborating with Global CTM to ensure country level study delivery is aligned with global study project plan
• Contributing to study-level risk assessments
• Leading and continually review regional risk mitigation activities to ensure study delivery to plan
• Overseeing regional insourcing/outsourcing partner deliverables to required standards
• Ensuring regional, country and site vendor set-up, conduct and quality e.g. laboratories and equipment provisioning
• Leading regional documentation and required tool and systems set-up
• Contributing to regional aspects of Drug Supply Plan
• Ensuring implementation of studies in accordance with SOPs and ICH/GCP guidelines
• Supporting audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate
• Supporting and contributing to Clinical Study Team
• Ensuring relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
• Ensuring key stakeholders are kept informed of study progress e.g. Global CTM, DOMs
• Contributing to development of study-specific materials e.g. monitoring plan, study specific training documents
• Participation in cross-functional task forces / process improvement groups
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• Activities outlined in Global FSP CRA Trainer Guide to ensure training according to agreed 5-week Onboarding Training Program
• Providing FSP CRAs with timely and correct information about updates on training requirements as e.g. SOP
• Providing training to FSP CRAs as required or requested by FSP CRA Line Manager, FSP Team;
• Conducting process visits, TMF SME manger activities and accelerated training
• Participating in FDA inspection, Sponsor audit and Country Regulatory Authority inspections.
• Scheduling Training Calls within 1 to 3 weeks of last 'Train the Trainer session
• Attending in 'Train the Trainer' session to certify for delivery of Training Calls material.
• Participation in frequent Amgen's calls scheduled to inform FSP trainers about changes in procedures, SOPs;
  
  

• Generates and utilizes metrics tools to assure study is running per timelines and to alert CRAs to potential issues with close cooperation with RCTM.
• Reviews some monitoring visit reports and assures adherence to study timelines for report submission and finalization
• Proactively prevents and identifies issues related to clinical portion of study, including study processes, monitoring or site issues
• Provides co-monitoring and other shadowing opportunities to junior members of team for training and development purposes as needed.
• Sets up and maintains Clinical Monitoring tracking tools and develops study tools and templates for
  monitors
• Develops study specific CRA training materials. Trains CRA team and oversees site retraining, tracks and maintains documentation of training throughout life of project
• Act as mentor and co-monitor with CRAs to ensure high quality as required

• Supervising staff (10 CRAs) – Mentor Peer Buddy
• Ensuring clinical study sites are conducting Amgen clinical trials in compliance with respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
• Evaluating, initiating, monitoring & closing out clinical trial sites
• Identifying site needs and site-related issues, escalating them and initiating corrective actions when necessary using Sponsor issues escalation processes (e.g. IPD, red issues, dosing deviations), providing solutions for site staff to facilitate clinical trial process
• Facilitating data flow and resolutions of clinical queries to investigative staff in accordance to study
• Performing IP accountability and reconciliation and maintaining site supplies
• Building and maintaining solid and long-term professional relationships with site staff
• Facilitating subject enrolment at site level with focused patient recruitment strategies and action plans
• Assisting in preparing sites for audits, reviewing audit reports and contributing to resolving findings
• Collaborating with study CTM for insight into issues and study deliverables to provide support and
  develop action plans
• Facilitating and maintaining strong external relationships e.g. Investigators, FSP and other stakeholders;
  

• Monitored studies; types of visits performed: pre-study, initiation, monitoring, close-out.
• Participated in feasibility process.
• Monitored unit budget to meet financial objectives for spend rate and funding
• Attended investigators' meeting.
• Participated in process of preparation of financial contracts.
• Prepared submissions to RA/IRBs
• Managed process of payment to sites, investigators, vendors