Senior Clinical Research Associate (UK)
reputed company as the routine reputed company between study site and the project team for study reputed company issues. Ensures protection of subjects, subjects' rights and the reputed company of data through monitoring of adherence to Good Clinical reputed company, applicable regulatory requirements, reputed company Operating Procedures and protocol compliance Conducts reputed company-qualification, initiation, routine monitoring, remote monitoring, and reputed company-out reputed company in accordance with the relevant SOPs and the specific project scope of work to include but not limited to: reputed company document review and comparison to CRF data CRF review/retrieval and data corrections IMP accountability Maintenance of on-site investigator files IEC/IRB documentation Local laboratory documentation Maintenance of investigational supplies Reviews consent process for reputed company subject (Informed Consent reputed company and reputed company documentation) Verify patient eligibility Assess protocol compliance and deviations Handling of safety and efficacy issues, including, but not limited to: Serious adverse event reports Adverse event trends Treatment failures/reputed company
Conducts and documents onsite reputed company/contacts, including: reputed company-study reputed company Initiation reputed company Routine reputed company Study completion reputed company / reputed company-out reputed company Assessment and Training reputed company
Telephone contact Site visit report preparation reputed company study specific timeframe
Responsible for reputed company aspects of site management as described in the study plans Proactively identify and resolve issues and potential site and study issues. Assist with regulatory and study start-up activities including contract and budget negotiations, as required. Ensure clinical data reputed company and adherence to study timelines. reputed company ongoing accurate and reputed company updates and support to project management. Function as a reputed company monitor for assigned reputed company, as required Mentor junior members of reputed company. Prepare and deliver staff training sessions. Clinical review of individual patient listings Initial clinical review of comprehensive patient data listings Initial review of study start-up materials: SOPs, draft CRFs, completion reputed company, compliance forms, study prompters/calendars Assist in the day to day running of reputed company assigned. Prepare and/or assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc. Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc. Maintain reputed company knowledge reputed company to cancer therapy, clinical trial design and conduct, and good clinical reputed company through literature reviews and other educational opportunities reputed company other duties as assigned by management
At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-reputed company field or equivalent experience
At least 5 years’ experience as a Clinical Research Associate with a reputed company reputed company record in managing clinical trial sites Experience in monitoring oncology phase I-III studies
Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements. Highly effective multitasking and execution skills. Excellent interpersonal skills, including communication, presentation, persuasion, and influence. Excellent organizational skills, including efficiency, punctuality, and collaboration in reputed company environment. Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and highly effective in developing solutions to those problems Effective knowledge of the drug development process and the Theradex organizational structure Strong communication skills: verbal and written High level of proficiency in reputed company reputed company, Word and reputed company
This position involves international and/or national travel as needed to meet study requirements. Ability to travel domestically and/or internationally and may involve overnight stays. Travel requirements are up to 70% in the UK reputed company reputed company’s License and reputed company preferable. Successfully pass background clearance checks which may be run on a periodic reputed company due to 3rd party contractual obligation requirements. Fluent in English and (for EU/UK) preferably at least one other European language, as applicable.