Justyna Stachelek

Responsibilities:
• Supporting the RSS team where applicable with regulatory and ethics submissions subject to resource needs e.g. non-substantial amendment submissions.
• Assisting in the development of Informed Consent Forms, labels and other patient facing material in accordance with country-specific requirements.
• Coordinating and/or performing the preparation, final quality control review, and submission of CTAA packages including initial submission, amendments and End of Trial Declarations as well as non-substantial notifications, status reports etc. to the CA and IRB/IECs and to any other country specific authority/body in assigned countries (except FDA).
• Preparing and responding to CA and EC/IRB and to any other country-specific authority/body after Regulatory Project Lead/Manager approval.
• Serving as local expert in project start-up activities for a particular country or region.

Responsibilities:
• Identifying potential centres for a proposed study in conjunction with the Project Team
• Preparing Multicentre Ethics Committee submission documentation (including preparation of PIS/ICF and Protocol Synopsis)
• Supporting Commercial Contracts with the preparation, sending to site and follow-up of site agreements and updating Site Agreement Management System
• Supporting Regulatory Affairs Department with the preparation of submission to Polish Regulatory
• Maintaining a list of country specific start-up requirements
• Translation and back translation of all necessary documents
• Ensuring that all relevant study documents is present for study sites during the start-up phase
• Responsible for preparing country and site level IP release packs in accordance with Chiltern SOPs

Responsibilities:
• Management (picking and preparation) for clinical documentation in accordance with SOP
• and GCP regulations (initiation, monitoring and close-out visits, audits);
• Monitoring, updating of essential documents in the Sponsor File;
• Collecting regulatory documentation
• Administrative orders under the internal system;
• Correspondence with Investigators, Monitors and Study Team;
• Support Centres and Investigators in case of CRA sick leave or holiday (office support);
• Conducting the Centre selection process (feasibility);
• Solving laboratory QUERIES;
• Prepare contracts and annexes (negotiating contracts with the centres, diagnostic centres, preparation of financial annexes);
• Settlement of Centres;
• Accruals preparation;
• Preparation of appropriate tools to improve CR-Sponsor communication (compilations, tables);
• Responsibility for CRO calendar of meetings and for the flow of reports prepared by contract monitors;
• Co-monitoring visits (drug clearance, ICF verification, Investigator File verification);
• Monitoring and verification of central document translation (Patient Consent, Protocols, Study Timelines);
• Organization of business trips, conference calls, live meetings, investigators meetings;
• Preparation of clinical documentation for archiving;
• Conduct Anti-Bribery and Corruption process;
• Working with the application : Siebel Clinical, Oracle Clinical, SAP
• Implementation new employees in operating systems and business policy;

Responsibilities:
• Work with pharmacy system ‘Kamsoft’ (medicines sale, order medicines);
• Medicines preparation;
• Control the storage and expiration date for pharmacy resources;
• Mandatory Trainings;

Responsibilities:
• The administrative and essential departments support;
• Management training for workers;
• Main office management;
• Coordination of cooperation with selected vendors;
• Introducing and implementing own projects in the field of organization;
• Document flow management - correspondence;

Responsibilities:
• Medicine and medical products expenditure using a pharmacy system 'KCZ Pharmacy' in accordance with a prescription;
• Medicine preparation;
• Control the storage and expiration date for pharmacy resources;
• Medicines inventory;

Practise in Research and Development Unit/Medical Unit

Practice in Pharmacy

Practice in Pharmacy

Summer Practice