Clinical Research Associate II North UK
Syneos Health are currently seeking a CRA II to work Sponsor Dedicated for a highly regarded establishment. In this role you will be Oncology focused with 8 site visits a month. D ue to the location of the sites, ideally the candidate would be based in Leeds, Liverpool, hull, Nottingham or within commutable distance. Clinical Research Associate (CRA / Field Monitor)
- Contribute to the identification of new sites for clinical trials; analyze capability and support
- CRMA and CSM in making recommendation for trial inclusion.
- Assume ambassadorial role to facilitate communication between sites and Novartis CPO to increase value proposition to investigators.
- Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF)
- During all phases of the trial ensure archiving per relevant SOP.
- Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators. Ensure adherence to payment schedule.
- Study Start-up
- Execute site initiation and training, generate initiation visit report.
- Study Execution
- Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
- Identify problems at sites; resolve issues and escalate as appropriate.
- Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
- Complete preparation and generation of visit monitoring reports as per relevant SOP
- Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
- If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues
What we're looking for
- Implement site close-out activities and generate site close-out report.
- Provide feedback on site performance for future trial site feasibility/selection General
- Improve skills by timely completion performance of assigned global and local training.
• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.