Hobson Prior are looking for a Lead CRA to join a biopharmaceutical organisation on a permanent basis, with the flexibility to be in the office 1 day a week. Our client is focused on developing specific therapies that harness the immune system to destroy cancer cells.
- Advances the site qualification and study site initiation processes including the conduct of Site Qualification and Site Initiation visits.
- Conducts Site Initiation visits in collaboration with Medical Monitors and/or Clinical Project Managers where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements regularly.
- Independently performs monitoring visits including site initiation, qualification, routine monitoring and close out visits.
- Critically reviews and analyses site activities through frequent visits and contacts to monitor study sites following the applicable study plans and applicable SOPs.
- Works across functions in the Company to ensure the readiness of supply kits.
- Manages multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- Ensures quality of data submitted from study sites, collects data from sites within established timelines and ensures timely follow up/submission on any requested information.
- Ensures site compliance, safety and protection of study patients according to the clinical study plans, SOPs, and ICH and/or FDA GCP Guidelines.
- Reviews adverse event reports (where required) and ensures site reporting of safety events in a timely manner.
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
- 5+ years CRA experience.
- Someone with UK early phase 1 or 2 oncology experience. (ideally Lung and melanoma).
- Ideally cell therapy experience.
- Previous small pharmaceutical/biotech experience preferred.
- Minimum of 3-5 years' monitoring experience, working as a CRA.
- Experience in monitoring oncology early phase studies.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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