Location: Home Based, Located Anywhere in the USA
Closing Date: 03 Nov 16
Type: Full Time
Salary (£): Competitive
Chiltern International has a great opportunity for a Clinical Team Lead with Oncology experience to join our growing clinical operations team in the United States. This position can be home-based anywhere in the US. Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.
The CTL is a position of responsibility within a project with the requirement to supervise one or more CRAs as the LCRA.
The CTL may also function as a Project Responsible Person (PRP) for single service studies.
As a high-profile role within the project, the CTL must be able to interact confidently with the Client, maintaining a professional image when working under time constraints, and act appropriately as a representative of the Company.
CTL should be able to use their experience as a ‘knowledge resource’ for the Department and to help other CRAs develop their skills.
They may be called upon to interact independently with Sponsors not directly involved in their projects, and to assist in wider Departmental tasks.
The CTL role provides functional leadership to a defined group of Clinical Monitoring staff working on a designated project (the Clinical Monitoring project team) to ensure satisfactory performance and completion of the project.
• Experience as a CRA and SCRA on multicentre trials, including the Lead CRA function, and also demonstrating some of the competencies expected within a Project Management function
• Positive outlook on the role of the Department and on Departmental or Company policy
• Good understanding of the work performed by other Chiltern International functions and how they interact
• Understanding of the principles of Project Management and appreciation of the wider issues affecting the efficiency and running of the department
• Proven ability for working independently with minimal supervision
• Proven experience in all clinical aspects of a trial with a strong knowledge of SOPs and accepted practices
• Proven experience of good interpersonal and communication skills when dealing with Sponsors, supporting colleagues and making presentations
• Able to organize and oversee multiple ongoing tasks, and understand the differing priorities
• Confident dealing with external and internal clients and providers
• Able to motivate other team members to achieve Project targets
• Proven ability to guide and supervise less experienced staff
• BSc or BA degree in a biomedical or related life science, or nursing qualification
• Approximately 4 years’ experience as a CRA, main function is Lead CRA for national and multinational studies
. • Demonstrated ability to conduct clinical monitoring activities effectively, efficiently and with the minimum of supervision • Good clinical knowledge with an understanding of medical terminology
• An understanding of the basics of physiology and pharmacology
• Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
• Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English.
• Experience working in a team environment under time and resource pressures
• Understanding of the principles of ICH GCP and regulatory requirements
• Experience of the clinical research process and terminology
• Preferable experience using a clinical trial management system (CPMS)
1016 W 9th Ave, King of Prussia, United States
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