Senior Clinical Research Associate
My Client is looking for an additional Senior Clinical Research Associate professional to join their relatively new but expanding Spanish Team
I am recruiting for an small but growing, award winning CRO who has been operating for over 20 years. Due to their continued success they are expanding their operations across Europe and recruiting for industry professionals to join their exciting new teams. They pride themselves on their scientific achievements and capabilities. They Provide full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trials.
The Senior Clinical Research Associate (Sr. CRA) will be responsible for monitoring activities in compliance with FDA regulations, ICH/GCP guidelines, SOPs and sponsor SOPs. CRA will Manage the activities of the clinical investigative sites to ensure successful execution of the protocol. Study assignments for Sr. CRA will include Investigator Initiated Trials as well as industry sponsored CRO trials.
Site assignments of the Sr. CRA will include community practices as well as higher complexity sites such as academic medical centers. Sr. CRAs will serve as a Lead CRA on Investigator Initiated or other trials as assigned by CRA Line Manager and/or Project Manager. The Sr. CRA will also ensure that trial data are accurate, complete, and verifiable from source documents. Work is performed under the general direction of the CRA Line Manager and Project Manager of assigned projects.
- Ensure safety and protection of study subjects according to the federal regulations
- Ensure consistent implementation and successful completion of clinical research activities for assigned studies by conducting site feasibility calls/questionnaires, site qualification visits, site initiation visits, routine monitoring visits, closeout visits and other visits in accordance with the monitoring plan and SOPs
- Act as the primary liaison between assigned sites and the study team
- Manage sites to ensure targets, metrics, and quality are maintained (site FPI, enrolment goals, data entry requirements and timelines, minimal quality issues
- Ensure appropriate management of quality issues through corrective action plan development with sites or other alternative solutions as per the monitor plan and project team determination.
- Communicate effectively with investigators and other research personnel, maintaining a professional demeanour
- Review source documentation to confirm subject eligibility for the clinical trial and to confirm that the correct informed consent process has been followed
- Bachelor degree in a science or related field and seven+ years related experience; OR ten years related experience and/or training in a clinical setting, science related field, or clinical research experience; OR equivalent combination of education and experience.
- Relevant work experience should include at least seven (7) years of Monitoring experience of which at least five (5) of those in oncology preferred
- Phase I oncology monitoring experience required
- CCRA or CCRP strongly preferred
- Must have exceptional communication skills in both verbal and written form
- Ability to sit, stand, walk, reach, climb or balance, stoop or crouch, hand/wrist use, talk, see, and hear for extended periods of time
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.
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