Hobson Prior currently have an opportunity for a CRA II to work remotely either in the North or South of the UK for a global pharmaceutical organisation who are driven to help improve and prolong life. This position will focus on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Regulations and ICH/GCP Guidelines

Job Responsibilities:

• To act as liaison between the in-house team, vendors, and multiple clinical sites.
• Accountable to work collaboratively with investigative sites to develop strong, long-term, working relationships.
• Help recognise and qualify potential investigators.
• You will apply SOPs, Clinical Monitoring Plan, study manuals and other materials and guidelines as applicable.
• Complete all type of visits from Pre-Study to Close out.
• Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
• Assist with start-up activities, including essential document review and collection as requested.
• Lead and drive regulatory Ethics Committee submission and site start-up activities in partnership with investigator sites including the support of EC follow up queries and responses as required.
• Communicate with sites to support contracts/budget negotiation and support the development and adaptation of country/site specific informed consent forms under the direction of the internal team.

Requirements:

• You are educated to degree level, have equivalent experience or be a licensed healthcare professional.
• Oncology experience is essential.
• Previous robust experience as a CRA working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
• Working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
• Experience in central submissions and hospital submissions as well as experience in contract negotiation.
• Experience working in oncology clinical trials.

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.