Job Reference: J5633791
Updated On: 16/09/2020
Status: Open to Applications
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Clinical Research Associate - Oncology / Viral
Role OverviewAre you an experienced Clinical Research Associate looking for a new exciting job opportunity?
We are currently looking for a Clinical Research Associate to join a leading life sciences company based in the Central Belt of Scotland with the possibility of home working.
As the Clinical Research Associate you will be responsible for the coordination of a variety of clinical trials in oncology and viral (cell immunotherapy) to ensure that trials are conducted in accordance with ICH GCP and other relevant regulatory guidelines, protecting the safety of participants and the quality of the data.
Key Duties and ResponsibilitiesYour duties as the Clinical Research Associate will be varied however the key duties and responsibilities are as follows:
1. You will take ownership of assigned studies and carry out site selection/feasibility, support to EC/RA submissions, initiations, on-site monitoring, and close-out activities.
2. You will be responsible for ensuring 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.
3. As the CRA, you will be establishing regular lines of communication plus administering protocol and related study training to assigned site as well as manage multiple priorities across various clinical trials.
4. Additionally, you will manage the clinical trial progress by tracking regulatory submissions, recruitment, case report form (CRF) completion and data query resolution.
Role RequirementsTo be successful in your application to this exciting opportunity as the Clinical Research Associate we are looking to identify the following on your profile and past history:
1. A Bachelor's degree in a health care or other scientific discipline as well as experience in monitoring as CRA within Oncology or Viral is essential for this position.
2. You will also need to have thorough knowledge of ICH GCP and other industry recognised standards and guidelines as well as conducting clinical trials in general.
3. Experience in site set up and regulatory and EX submissions in EU and US would be advantageous. Any experience in haematology, immunotherapy and/or cell therapy would also be beneficial.
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