Career - Offer
Trainer / Senior CRA Oncology
Type of job: full-time
Are you looking for a great opportunity to work for globally developing company who will care for you? With more than 100 000 employees all around the world in our branches in more than 143 countries, we share our vision of better present and future for our patients - a vision that is our driving force of further development and success. The biggest satisfaction in what we do is in the awarness of giving better quality to a human life. We prolong it and save it as well - we do everything with accuracy and impact, with help of the newest innovation and breakthrough science knowledge.
Are you looking for a great opportunity to work for globally developing company who will care for you? With more than 100 000 employees all around the world in our branches in more than 143 countries, we share our vision of better present and future for our patients - a vision that is our driving force of further development and success. The biggest satisfaction in what we do is in the awarness of giving better quality to a human life. We prolong it and save it as well - we do everything with accuracy and impact, with help of the newest innovation and breakthrough science knowledge.
JOB PURPOSE:
To ensure required trainings / supervision of oncology CRAs so that clinical trials are monitored as per Novartis SOPs and GCP and local legislation. Identify skills and competency gaps.
To organize, manage and monitor phase I - IV oncology clinical trials, to assure delivery of high quality clear data / CRFs by adherence to Good Clinical Practice, to ensure investigator's compliance with protocol and trial procedures as well as timely trial initiation /completion.
TRAINER RESPONSIBILITIES:
- coordination of the completion of individual introductory CRA training
- organization of the group trainings for CRAs based on the request of CRA GC - e.g. introductory group training, workshop and group trainings on new procedures, guidelines, legislation etc.
- supervising, coaching and regular training of CRAs with regard to all aspect of drug development and clinical trial process
- regular co-monitoring visits with CRAs, including TMF check, followed by well defined corrective actions and final check of corrections performance
- supervision of the CRAs so that required level of knowledge and skills is present and trials sites are monitored as per SOPs. Identify skills and competency gaps. Assist to develop training plans and coordinate training.
- preparation of new WPs/SOPs/ SOPs/WPs updates based on the request of CRA GC or Head Medical Oncology BU
- participation in the general and project-specific trainings
- MVR check (based on request of CRA GC)
- role ClinAdmin, EDC, CREDI superuser
- compilation, completion, dispensing and archiving of all trial documentation on the company side (Investigator's Brochure, Protocol and Amendments, Informed Consent, Case Report Forms etc.) and on the investigator side (signed documents, CVs, patient information and consent forms etc.)
- participation in the proper investigator/site selection
- submission of the trial documentation to regulatory authorities granting the relevant approvals (IRB/IEC, Competent Health Authority - SUKL)
- participation in the investigator grants negotiations, trial agreement preparation and investigator payment status tracking, ensuring adherence to the payment schedule
- participation in the preparation of investigator meetings
- trial material (including trial medication) dispensation and accountability, destruction
- timely trial centre initiation as per plan, accordingly planned field monitoring
- timely preparation of monitoring reports
- investigational site performance assessment
- CRFs transmission and checking CRFs completion
- participation in the SAEs processing (incl. Investigator Notifications)
- trial centre close-out
- participation in the clinical database completion and locking
- follow up of current developments in the field of clinical research, participation in the general and project-specific training
- performance of special assignments, as discussed with the GMO Group Coordinator and Head Medical BU Oncology
CANDIDATE REQUIREMENTS:
- University Degree in Nature Sciences, Pharmacy, Medicine
- previous experience with clinical research area at least 3 years
- fluent English (both written and spoken)
- very good PC skills (MS Office - esp. Word, Excel)
- reliable, precise
- willing to learn more
- detail focused
- flexible, driving licence B
WE OFFER:
- opportunity to grow professionally in successfull international company
- good financial compensation + interesting bonus system
- employee benefits (5 weeks holiday, 4 days sick-leave, company car for private use, meal vouchers, benefits from the area of culture, sport, health and education based of own choice, pension scheme, risk life insurance)
- friendly working environment
Should you be interested in this position, please send your structured CV in both English and Czech language to the contact stated below.
Contact:
Mgr. Denisa Adamová
Updated: 19.10.2012
