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Hobson Prior currently have an exciting opportunity for an 2x CRA's (Oncology) to join a leading Pharmaceutical organisation who focus on delivering life-changing medicines. This position will be field based and UK travel will be expected. As a CRA you will be responsible for working across up to 4/5 studies at one given time at up to 5 different UK sites.
- You will be training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management principles.
- To be driving performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
- You will be responsible for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
- You will be ensuring that the staff have completed and documented the required trainings correctly, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
- You will actively participate in Local Study Team meetings.
- Initiates, monitors and closes study sites in compliance with the organisation Procedural Documents. Shares information on patient recruitment and study site progress within the LST.
- You will ensure that data query resolution in a timely manner.
- Manages study supplies, drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
- Performs monitoring visits, as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSM the correct timing and type of visits.
- Any other assigned duties.
- Excellent attention to details.
- Good written and verbal communication skills.
- Good collaboration and interpersonal skills.
- Good negotiation skills.
- Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Ability to travel nationally/internationally as required.
- Valid driving license.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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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