Clinical Research Associate
My client is an emerging cancer immunotherapy company developing cell-based treatments for cancer and severe viral infections. The company have a clear vision to make a mainstream therapy for eradicating cancer. They are developing safer, cheaper, consistent and durable drugs for haematological and solid tumours.
Due to recent expansion an opening has come up for an Clinical Research Associate, with a minimum of 2 years of experience, who will be responsible for the coordination of a variety of clinical trials in oncology (cell immunotherapy) to ensure the trial is conducted in accordance with ICH GCP and other relevant regulatory guidelines.
Responsibilities include but are not limited to:
+ To ensure appropriate attention is provided to the sites in order to drive data quality so that the clinical study protocol requirements are fulfilled within the appropriate regulatory and ethical framework.
+ Experience of performing site start up procedures, routine monitoring and site closure.
+ Ability to manage multiple priorities across various clinical trials
+ Establishing regular lines of communication plus administering protocol and related study training to assigned site
+ Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
Essential skills & experience:
+ Must have at least 2 years of monitoring experience as CRA (oncology or viral required).
+ Experience in site set up and regulatory and EC submissions in EU and US would be an advantage.
+ Experience in haematology, immunotherapy and/or cell therapy would be an advantage.
+ Thorough knowledge of ICH GCP and other industry-recognised standards and guidelines and conducting clinical trials in general.
+ Excellent inter-personal, organisational, presentation and written communication skills.
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