Offers

TRAINER / Senior Clinical Research Associate Oncology/onlu

You will be responsible in trainings/supervision of oncology CRAs so that clinical trials are monitored as per companies 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 super user
CRA RESPONSIBILITIES

•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.

We are looking for candidates with since degree and ideal candidates will have minimum of 3 year’s of professional experience from international pharmaceutical or CRO industry. Must be able to work in a multicultural team environment and interact with a wide variety of customers. Excellent English language skills.

In case of interest please send your CV to Lucie Ondruchová at ondruchova@hays.cz