Hobson Prior are looking for a Senior CRA to join a growing biotech organisation on a permanent basis in Hammersmith. Our client is focused on developing specific therapies that harness the immune system to destroy cancer cells.

Job Responsibilities:

• Accountable for on-site and remote confirmation of the source data verification of eCRFs and Data clarification forms; management of multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
• Ensure operational readiness and clinical supply communication.
• To ensure quality of data submitted from study sites and collect data from your sites within established timelines and ensuring timely follow up/submission on any requested information.
• Ensure site compliance, safety and protection of study patients according to the clinical study plans, SOPs, and ICH and/or UK/EU and FDA GCP Guidelines and appropriate follow up and documentation of items requiring investigation.
• You will work with site personnel/study team to prevent address and resolve issues.
• While monitoring early phase oncology studies you will need to have a good focus for safety and will review adverse event reports and ensure site reporting of safety events in a timely manner.
• You will need to have a keen eye for detail to prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
• Your key site interactions will be with a variety of study personnel (study coordinator, investigator, pharmacist & cell therapy team members), peers and office-based personnel.

Key Skills:

• You are a good communicator with the ability to influence at every level.
• Proactive and someone who looks to make connections and is confident enough to push when they see action is required.

Requirements:

• Bachelor's degree (BSc, BA or RN equivalent) in biological or science-related field is essential.
• Previous small pharmaceutical/biotech experience would be preferred.
• At least 3-5 years' monitoring experience, working as a CRA.
• Experience in monitoring oncology early phase studies.
• Experience with ATIMPs and/or FiH studies an advantage.
• Strong clinical, technical or disease area expertise.
• Knowledge of medical terminology and clinical patient management and pathways.
• A valid UK driving licence
• Computer literacy, proficiency in Microsoft Office, eTMF and eCRF
• You will need to be available for site travel up to 60% of the time, including overnight stays as necessary
• Demonstrated understanding of Cell and Gene Therapy.
• In-depth knowledge of ICH Guidelines and GCP including a basic understanding of regulatory.

Apply now:

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.